<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="research-article" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.133911.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Research Article</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Assessment of Temporomandibular Joint for Occurrence and Severity of Disorders in Adult Cases with Unilateral Cleft Lip and Palate and Non-Cleft Class I Using Helkimo Index</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: awaiting peer review]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Kumar</surname>
                        <given-names>Nikhil</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Data Curation</role>
                    <role content-type="http://credit.niso.org/">Formal Analysis</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <uri content-type="orcid">https://orcid.org/0000-0001-5918-2142</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Daigavane</surname>
                        <given-names>Pallavi</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a2">2</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>orthodontics and dentofacial orthopaedic, datta meghe institute of higher education and research, sawangi, wardha, maharashtra, 442001, India</aff>
                <aff id="a2">
                    <label>2</label>Orthodontic and dentofacial orthopaedics, Datta meghe institution of higher education and research, sawangi, wardha, maharastra, 442001, India</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:drnikhilkr6032@gmail.com">drnikhilkr6032@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>5</day>
                <month>5</month>
                <year>2023</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2023</year>
            </pub-date>
            <volume>12</volume>
            <elocation-id>470</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>28</day>
                    <month>4</month>
                    <year>2023</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2023 Kumar N and Daigavane P</copyright-statement>
                <copyright-year>2023</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/12-470/pdf"/>
            <abstract>
                <p>Background: Cleft lip and palate is congenital anomalies. Cleft patients are more akin toward surgical treatment plan neglecting the dental treatment aspects as aesthetic is main concern of patient bond to have malocclusion. Which may contribute to Temporomandibular joint disorder (TMDs) in cleft patients.</p>
                <p>Methods: A total 40 patients (20 cleft patients and 20 non cleft class I) were taken in the study. patients&#x2019; selection was done based on inclusion and exclusion criteria. Helkimo index was used for both subjective and clinical assessment for TMDs in both groups.</p>
                <p>Results: Cleft patients shows significant symptom of TMD between range of mild to severe while non cleft I cases showing mostly mild to moderate symptom of TMDs.</p>
                <p>Conclusions: It was found that Unilateral cleft lip and palate (UCLP) cases shows higher occurrence of TMDs in comparison with non-cleft class I group.</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Cleft lip and palate</kwd>
                <kwd>temporomandibular joint</kwd>
                <kwd>temporomandibular disorder</kwd>
                <kwd>Helkimo index</kwd>
                <kwd>unilateral cleft lip and palate</kwd>
                <kwd>non-cleft class I</kwd>
            </kwd-group>
            <funding-group>
                <funding-statement>The author(s) declared that no grants were involved in supporting this work.</funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <p>Lack of fusion between the frontonasal and maxillary processes causes clefts through the lip, alveolus, and floor of the nose in people with cleft lip. Cleft palate is a birth defect that occurs when the palatal shelves of the maxillary processes do not fuse together properly, resulting in a split in either the roof of the mouth or palatal velum. The precise location at which they show up is governed by the areas of the face in which the fusion of different facial processes did not take place. This, in turn, is impacted by the point in an embryo's life at which some form of interference with development took place.
                <sup>
                    <xref ref-type="bibr" rid="ref1">1</xref>
                </sup>
            </p>
            <p>Patients with cleft lip and palate, as well as their parents, give greater importance to the surgical correction of cleft anomalies and less importance to the other concerns related to oral health, and structural co-ordination skeletal as well as dental malocclusion.
                <sup>
                    <xref ref-type="bibr" rid="ref2">2</xref>
                </sup>
            </p>
            <p>Malocclusion is an abnormality that causes disfigurement or gets in the way of function. It needs to be corrected if the disfigurement or function problem is likely to hurt the patient's physical or mental health.
                <sup>
                    <xref ref-type="bibr" rid="ref3">3</xref>
                </sup>
            </p>
            <p>Certain functional issues could arise if there is an interference or deviation in the occlusion or the occlusal plane that becomes more pronounced and starts to resemble the slope of the articular eminence of the temporomandibular joint. 1) Loss of canine occlusion, 2) Loss of incisal guidance, and 3) the emergence of interference with functioning and non-working posterior dental function. Pullinger 
                <italic toggle="yes">et al</italic>., (1993) stated that people with Temporomandibular joint disorder (TMD) may be more likely to have occlusal factors like a large horizontal overlap, minimal vertical overlap, anterior skeletal open bite, unilateral posterior crossbite, occlusal slides greater than 2 mm, and no teeth in posterior region.
                <sup>
                    <xref ref-type="bibr" rid="ref4">4</xref>
                </sup> Crossbites and Class III malocclusion are the most common occlusal abnormalities as compared to class II malocclusion affecting the craniomandibular structures.
                <sup>
                    <xref ref-type="bibr" rid="ref5">5</xref>
                </sup>
            </p>
            <p>&#x201c;TMD is a group of orofacial disorders characterized by pain in the preauricular area, TMJ or muscles of mastication, limitations and deviations in the range of motion of the lower jaw, and sounds in the TMJ during functioning of the jaw, according to Laskin 
                <italic toggle="yes">et al</italic>.'s 1983 definition of TMD (American Dental Association, 1983).&#x201d;.
                <sup>
                    <xref ref-type="bibr" rid="ref6">6</xref>
                </sup> TMD is thought to be multifactorial in nature. TMD symptoms include muscular pain, deviation or deflection of the lower jaw, locking of the jaw, and the presence of clicking sounds when opening and closing the mouth.
                <sup>
                    <xref ref-type="bibr" rid="ref7">7</xref>
                </sup> Untreated malocclusions, unstable occlusions, stress and other psychologic reasons, trauma, individual predispositions, and structural abnormalities are only a few of the theories put forth to explain the aetiology of TMD.
                <sup>
                    <xref ref-type="bibr" rid="ref8">8</xref>
                </sup>
            </p>
            <p>Finding a less complicated and quicker techniques for diagnostic method of TMD in primary care would be useful. A common clinical diagnostic tool for TMDs is the Helkimo Index.
                <sup>
                    <xref ref-type="bibr" rid="ref9">9</xref>
                </sup> It is a simplified assessment that evaluates joint function, joint discomfort, and mandibular mobility and its restrictions while movement.
                <sup>
                    <xref ref-type="bibr" rid="ref10">10</xref>
                </sup>
            </p>
            <p>The treatment in cleft is limited to dental correction, skeletal correction with orthognathic surgery. But the functional correction is still a query in the cleft cases. There are limited evidences available where in the TMJ was evaluated for the TMD in cleft. With this hypothesis, thus the following study was planned to evaluate the occurrence of temporomandibular disorder in cleft patients.</p>
            <p>The aim of this study is to evaluate and compare adult instances of Unilateral cleft lip and palate (UCLP) and non-cleft class I for the presence and severity of abnormalities in the temporomandibular joints using Helkimo index.</p>
        </sec>
        <sec id="sec2" sec-type="methods">
            <title>Methods</title>
            <sec id="sec3">
                <title>Ethics</title>
                <p>Ethical approval was obtained from Institutional Research Ethical Committee of Datta Meghe Institute Of Medical Sciences. The ethical approval letter was obtained on 24
                    <sup>th</sup> December 2020 (approval number: DMIMS(DU)/IEC/2020-21/9398). Written informed consent was obtained from all participants.</p>
            </sec>
            <sec id="sec4">
                <title>Study design</title>
                <p>An observational study was designed to evaluate and compare the occurrence and severity of TMD in UCLP cases using Helkimo index. The study was conducted in the &#x201c;Department of Orthodontics and Dentofacial Orthopedics&#x201d;, &#x201c;Sharad Pawar Dental College, Sawangi Meghe&#x201d;, Wardha after obtaining clearance from the &#x201c;Institutional Research Ethics Committee of &#x201c;Datta Meghe Institute of Higher Education and Research, deemed to be University&#x201d;.</p>
                <p>The 
                    <italic toggle="yes">eligibility criteria</italic> for sample selection were as follows:
                    <list list-type="alpha-upper">
                        <list-item>
                            <label>A)</label>
                            <p>
                                <italic toggle="yes">Inclusion criteria for cleft cases:</italic>
                            </p>
                            <list list-type="order">
                                <list-item>
                                    <label>1.</label>
                                    <p>Uclp</p>
                                </list-item>
                                <list-item>
                                    <label>2.</label>
                                    <p>Aged 16 to 20 years old</p>
                                </list-item>
                                <list-item>
                                    <label>3.</label>
                                    <p>Male or Female</p>
                                </list-item>
                                <list-item>
                                    <label>4.</label>
                                    <p>All permanent teeth present with all erupted 1
                                        <sup>st</sup> and 2
                                        <sup>nd</sup> molars</p>
                                </list-item>
                            </list>
                        </list-item>
                        <list-item>
                            <label>B)</label>
                            <p>
                                <italic toggle="yes">Inclusion criteria for non-cleft cases:</italic>
                            </p>
                            <list list-type="order">
                                <list-item>
                                    <label>1.</label>
                                    <p>Angle&#x2019;s Class I bimaxillary, Skeletal and Dentoalveloar</p>
                                </list-item>
                                <list-item>
                                    <label>2.</label>
                                    <p>Aged 16 to 20 years old</p>
                                </list-item>
                                <list-item>
                                    <label>3.</label>
                                    <p>Male or female</p>
                                </list-item>
                                <list-item>
                                    <label>4.</label>
                                    <p>All permanent teeth present with all erupted 1
                                        <sup>st</sup> and 2
                                        <sup>nd</sup> molar.</p>
                                </list-item>
                            </list>
                        </list-item>
                        <list-item>
                            <label>C)</label>
                            <p>
                                <italic toggle="yes">Exclusion Criteria for cleft cases:</italic>
                            </p>
                            <list list-type="order">
                                <list-item>
                                    <label>1.</label>
                                    <p>Patients who had any orthopedic or orthodontic treatment previous to the research</p>
                                </list-item>
                                <list-item>
                                    <label>2.</label>
                                    <p>Bclp (bilateral cleft lip and palate)</p>
                                </list-item>
                                <list-item>
                                    <label>3.</label>
                                    <p>Only cleft lip involved</p>
                                </list-item>
                                <list-item>
                                    <label>4.</label>
                                    <p>Only anterior alveolus cleft involved</p>
                                </list-item>
                                <list-item>
                                    <label>5.</label>
                                    <p>Syndromic cleft patients</p>
                                </list-item>
                                <list-item>
                                    <label>6.</label>
                                    <p>TMJ Ankylosis patients</p>
                                </list-item>
                            </list>
                        </list-item>
                        <list-item>
                            <label>D)</label>
                            <p>
                                <italic toggle="yes">Exclusion Criteria for non-cleft cases:</italic>
                            </p>
                            <list list-type="order">
                                <list-item>
                                    <label>1.</label>
                                    <p>Skeletal and dentoalveolar Class II, Class III</p>
                                </list-item>
                                <list-item>
                                    <label>2.</label>
                                    <p>Cases with missing teeth</p>
                                </list-item>
                                <list-item>
                                    <label>3.</label>
                                    <p>Grossly carious teeth</p>
                                </list-item>
                                <list-item>
                                    <label>4.</label>
                                    <p>Open bites</p>
                                </list-item>
                            </list>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec5">
                <title>Sample selection</title>
                <p>Patients visiting the Departmental of Orthodontic &amp; Smile train outpatient Department (OPD), Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, Maharashtra, India, for orthodontic treatment, were screened. Elaborative case history and clinical examination (intraoral and extraoral) of the cases was recorded to select patients to meet inclusion and exclusion criteria of the study. Lateral radiographs were assessed for the skeletal criteria&#x2019;s (class I and dentoalveolar bimaxillary cases) with the help of Steiner analysis and Downs analysis for non-cleft Class I group. Sex of the participants was defined based on self report.
                    <disp-formula id="e1">
                        <mml:math display="block">
                            <mml:mtext mathvariant="italic">Study size</mml:mtext>
                            <mml:mo>:</mml:mo>
                            <mml:mi mathvariant="normal">n</mml:mi>
                            <mml:mo>=</mml:mo>
                            <mml:mn>2</mml:mn>
                            <mml:mspace width="0.25em"/>
                            <mml:mi>&#x03b1;</mml:mi>
                            <mml:mo>/</mml:mo>
                            <mml:msup>
                                <mml:mn mathvariant="italic">2</mml:mn>
                                <mml:mn mathvariant="italic">2</mml:mn>
                            </mml:msup>
                            <mml:mo>&#x2217;</mml:mo>
                            <mml:mo>&#x2009;</mml:mo>
                            <mml:msup>
                                <mml:mi>p</mml:mi>
                                <mml:mo>&#x2217;</mml:mo>
                            </mml:msup>
                            <mml:mfenced close=")" open="(">
                                <mml:mrow>
                                    <mml:mn mathvariant="italic">1</mml:mn>
                                    <mml:mo>&#x2212;</mml:mo>
                                    <mml:mi>P</mml:mi>
                                </mml:mrow>
                            </mml:mfenced>
                            <mml:mo>/</mml:mo>
                            <mml:msup>
                                <mml:mi>d</mml:mi>
                                <mml:mn mathvariant="italic">2</mml:mn>
                            </mml:msup>
                        </mml:math>
                    </disp-formula>
                </p>
                <p>
                    <italic toggle="yes">Where</italic> 2&#x03b1;/2 is the threshold of significance at 5% i.e 95% confidence interval =1.96, Confidence interval =1.96, P= prevalence of UCLP =0.7%=0.007, d = desired error of margin =5%=0.05, n= 1.96
                    <sup>2</sup>*0.007*(1-0.007)/0.005
                    <sup>2</sup> =10.68 = 11. Total sample size was taken as 40 cases (20 in each group).</p>
            </sec>
            <sec id="sec6">
                <title>Data collection</title>
                <p>After fulfilling the criteria of inclusion and exclusion, two groups each comprising of twenty patients were finalized. Group 1 consisted of twenty UCLP and Group 2 consist of twenty non-cleft Class I patients. The selected patients were informed about the nature and need of the study in their own language of understanding. Written informed consent was obtained from patients who agreed to take part in the trial.</p>
            </sec>
            <sec id="sec7">
                <title>Methods</title>
                <p>The evaluation of cases for TMD was done using Helkimo index. Before evaluation of temporomandibular joint, the muscle of mastication had to be relaxed. Patient were made to sit straight on dental chain. For making muscle of mastication in relax position, patients were either asked to take sip of water and swallow it (command method) or patients are distracted by casual talk other than clinical examination related talk (non-command method) or patients is asked to speak the letter M two to three times (phonetic method).</p>
                <p>Helkimo index consists of amnestic and dysfunction components.</p>
                <p>The first of these is the amnestic index, which is based on the many symptoms of masticatory system dysfunction (a non-objective symptom): Ai-0: Shows persons without signs of malfunction; Ai-I depicts people with mild dysfunctional symptoms, while Ai-II shows those with severe dysfunctional symptoms.
                    <sup>
                        <xref ref-type="bibr" rid="ref11">11</xref>
                    </sup>
                </p>
                <p>
                    <underline>
                        <bold>Questionnaire for anamnestic component</bold>
                    </underline>
                    <list list-type="bullet">
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Do you hear a clicking sound around your TMJ? Yes, No</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Does your jaw spasm when you first wake up or does your mouth move slowly? Yes, No</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Do you get jaw fatigue?&#x00a0;Yes, No</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Do you have trouble opening your mouth? Yes, No</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Do you have a locked mandible while opening your mouth? Yes, No</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Do you have pain in the TMJ or around your masticatory muscles? Yes, No</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Do you feel distress when moving your mouth? Yes, No</p>
                        </list-item>
                        <list-item>
                            <label>&#x2022;</label>
                            <p>Do you have a mandibular luxation? Yes, No</p>
                        </list-item>
                    </list>
                </p>
                <p>Patients were asked to sit up straight in the dental chair while the Frankfort Plane was maintained parallel to the floor by palpating the lower edge of the bony orbit and the furthest forward point in the supra tragal notch, which is the notch above the anterior cartilaginous projections of the external ear.</p>
                <p>The clinical index of dysfunction (Di) examination
                    <sup>
                        <xref ref-type="bibr" rid="ref12">12</xref>
                    </sup>:
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Mobility index (MI): Normal range of mandibular motion, described as opening of mouth greater than equal to 40 mm and horizontal movements greater than equal to 7 mm graded as 0 point; moderately impaired equals to 1 point; and severely impaired equals to 5 point.</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>TMJ function impaired: if TMJ noises is heard in one or both joints and/or deviation of greater than 2 mm than score is 1; locking and/or luxation of the TMJ score 5. Path of closer and auscultation method is used for diagnosis.</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>Masticatory muscle pain: 0 points if the masticatory muscles are not tender to palpation; 1 point if the muscles are tender to palpation at 1-3 sites; and 5 points if the muscles are tender to palpation at 4 or more sites. Muscles involved for palpation are elevator and depressor muscle of mastication.</p>
                        </list-item>
                        <list-item>
                            <label>4.</label>
                            <p>Pain in TMJ: 0 points for no palpable tenderness, 1 point for lateral and 5 points for posterior palpable soreness. The calibration of the middle finger, along with the other two fingers, is employed for support while walking laterally and posteriorly to the capsule.</p>
                        </list-item>
                        <list-item>
                            <label>5.</label>
                            <p>Pain in path of mandibular movement: Pain on one way movement = 1 point; pain on two or more ways movements = 5 points; no pain on either way of movements = 0 points.</p>
                            <p>Zero points (dysfunction group 0) free of clinical symptoms = Di0; 1-4 points Di I with a mild dysfunction score of 5 to 9 (Group 1); Severe dysfunction is categorized as Di III, It varies from 10 to 13 points (Group 2), 15 to 17 points (Group 3), and 20 to 25 points (Group 4).</p>
                        </list-item>
                    </list>
                </p>
            </sec>
        </sec>
        <sec id="sec8" sec-type="results">
            <title>Results</title>
            <p>Statistical analysis was done by using descriptive and inferential statistics using Chi square test and student&#x2019;s unpaired t test and p&lt;0.05 was considered as level of significance.</p>
            <p>In Group I, 10% cases showed no symptoms of TMD, 40% cases showed mild symptoms. Among the severe symptoms 10% showed difficulty in mouth opening, 10% cases showed mandibular dislocation along with its painful movement and 30% showed pain the TMJ region and in the masticatory muscles. Locking of the jaw was not present in the cases.</p>
            <p>In Group II, 60% cases showed no symptoms of TMD, 40% cases showed mild symptoms and no cases showed severe symptoms. This was found to be statistically significant with p value (p=0.018), chi square test &#x03d7;2-value was 17.14. (
                <xref ref-type="table" rid="T1">Table 1</xref>, 
                <xref ref-type="fig" rid="f1">Figure 1</xref>)</p>
            <table-wrap id="T1" orientation="portrait" position="float">
                <label>Table 1. </label>
                <caption>
                    <title>Comparison of Helkimo Anamnestic index score in two groups.</title>
                </caption>
                <table content-type="article-table" frame="hsides">
                    <thead>
                        <tr>
                            <th align="left" colspan="1" rowspan="1" valign="top">HELKIMO Score</th>
                            <th align="left" colspan="1" rowspan="1" valign="top"/>
                            <th align="left" colspan="1" rowspan="1" valign="top">UCLP</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">Class I</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">&#x03d7;2-value</th>
                        </tr>
                    </thead>
                    <tbody>
                        <tr>
                            <td align="justify" colspan="1" rowspan="1" valign="top">No symptoms</td>
                            <td colspan="1" rowspan="1"/>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">2(10%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">12(60%)</td>
                            <td align="justify" colspan="1" rowspan="7" valign="middle">17.14
                                <break/>P=0.0018, S</td>
                        </tr>
                        <tr>
                            <td align="justify" colspan="1" rowspan="1" valign="top">Mild symptoms</td>
                            <td colspan="1" rowspan="1"/>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">8(40%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">8(40%)</td>
                        </tr>
                        <tr>
                            <td align="justify" colspan="1" rowspan="4" valign="top">Severe symptoms</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">A) Difficulty in mouth opening</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">2(10%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">0(0%)</td>
                        </tr>
                        <tr>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">B) Jaw Locking</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">0(0%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">0(0%)</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="middle">C) Mandible dislocation and its painful movements</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">2(10%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">0(0%)</td>
                        </tr>
                        <tr>
                            <td align="left" colspan="1" rowspan="1" valign="middle">D) Painful TMJ region and/or masticatory muscles</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">6(30%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">0(0%)</td>
                        </tr>
                        <tr>
                            <td colspan="1" rowspan="1"/>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">Total</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">20(100%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">20(100%)</td>
                        </tr>
                    </tbody>
                </table>
            </table-wrap>
            <fig fig-type="figure" id="f1" orientation="portrait" position="float">
                <label>Figure 1. </label>
                <caption>
                    <title>Comparison of Helkimo Anamnestic index score in two groups.</title>
                </caption>
                <graphic id="gr1" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/146928/f4063e50-345f-431e-a302-2c94c5522966_figure1.gif"/>
            </fig>
            <p>In Group I, 35% of cases showed mild symptoms of TMD, 30% cases showed moderate symptoms and 35% cases showed severe symptoms. In Group II, 25% cases showed no symptoms of TMD, 70% cases showed mild symptoms and 5% showed moderate symptoms. This was found to be statistically significant with p value (p=0.0005), chi square test &#x03d7;2-value was 17.90. (
                <xref ref-type="table" rid="T2">Table 2</xref>, 
                <xref ref-type="fig" rid="f2">Figure 2</xref>)</p>
            <table-wrap id="T2" orientation="portrait" position="float">
                <label>Table 2. </label>
                <caption>
                    <title>Comparison of Helkimo Dysfunction index score in two groups.</title>
                </caption>
                <table content-type="article-table" frame="hsides">
                    <thead>
                        <tr>
                            <th align="left" colspan="1" rowspan="1" valign="top">Dysfunction (di)</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">UCLP</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">Class I</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">&#x03d7;2-value</th>
                        </tr>
                    </thead>
                    <tbody>
                        <tr>
                            <td align="justify" colspan="1" rowspan="1" valign="top">No Symptom (0)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="top">0(0%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="top">5(25%)</td>
                            <td align="justify" colspan="1" rowspan="5" valign="middle">17.90
                                <break/>P=0.0005, S</td>
                        </tr>
                        <tr>
                            <td align="justify" colspan="1" rowspan="1" valign="top">Mild Symptom (1-4)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="top">7(35%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="top">14(70%)</td>
                        </tr>
                        <tr>
                            <td align="justify" colspan="1" rowspan="1" valign="top">Moderate Symptom (5-9)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="top">6(30%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="top">1(5%)</td>
                        </tr>
                        <tr>
                            <td align="justify" colspan="1" rowspan="1" valign="top">Severe Symptom (10-25)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="top">7(35%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="top">0(0%)</td>
                        </tr>
                        <tr>
                            <td align="justify" colspan="1" rowspan="1" valign="top">Total</td>
                            <td align="justify" colspan="1" rowspan="1" valign="top">20(100%)</td>
                            <td align="justify" colspan="1" rowspan="1" valign="top">20(100%)</td>
                        </tr>
                    </tbody>
                </table>
            </table-wrap>
            <fig fig-type="figure" id="f2" orientation="portrait" position="float">
                <label>Figure 2. </label>
                <caption>
                    <title>Comparison of Helkimo Dysfunction index score in two groups.</title>
                </caption>
                <graphic id="gr2" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/146928/f4063e50-345f-431e-a302-2c94c5522966_figure2.gif"/>
            </fig>
            <p>In Group I, the mean value of Helkimo dysfunction score was 7.50 with mean standard deviation of 4.08, mean standard error 0.91. In Group II, the mean value of Helkimo dysfunction score was observed 1.65 with standard deviation of 1.42, standard mean error 0.31. This was found to be statically significant with p value (p=0.0001) and student unpaired t value 6.04. (
                <xref ref-type="table" rid="T3">Table 3</xref>, 
                <xref ref-type="fig" rid="f3">Figure 3</xref>)</p>
            <table-wrap id="T3" orientation="portrait" position="float">
                <label>Table 3. </label>
                <caption>
                    <title>Comparison of Helkimo Dysfunction mean score in two groups.</title>
                </caption>
                <table content-type="article-table" frame="hsides">
                    <thead>
                        <tr>
                            <th align="left" colspan="1" rowspan="1" valign="top">Group</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">N</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">Mean</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">Std. Deviation</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">Std. Error Mean</th>
                            <th align="left" colspan="1" rowspan="1" valign="top">t-value</th>
                        </tr>
                    </thead>
                    <tbody>
                        <tr>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">UCLP</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">20</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">7.50</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">4.08</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">0.91</td>
                            <td align="justify" colspan="1" rowspan="2" valign="middle">6.04
                                <break/>P=0.0001,S</td>
                        </tr>
                        <tr>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">Class I</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">20</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">1.65</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">1.42</td>
                            <td align="justify" colspan="1" rowspan="1" valign="middle">0.31</td>
                        </tr>
                    </tbody>
                </table>
            </table-wrap>
            <fig fig-type="figure" id="f3" orientation="portrait" position="float">
                <label>Figure 3. </label>
                <caption>
                    <title>Comparison of Helkimo Dysfunction mean score in two group.</title>
                </caption>
                <graphic id="gr3" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/146928/f4063e50-345f-431e-a302-2c94c5522966_figure3.gif"/>
            </fig>
        </sec>
        <sec id="sec9" sec-type="discussion">
            <title>Discussion</title>
            <p>Clefts arise during the fourth developmental stage. Orofacial clefts are typically classified as either cleft lip with or without cleft palate or cleft palate only. Malocclusion may be associated with one or more of the following: malalignment of individual teeth in each arch, mismatch of dental arches relative to the normal occlusion (in antero-posterior, vertical, or transverse planes), or lack of posterior teeth. Patients with TMD have been said to have higher rates of occlusal characteristics like a significant overjet, a small overbite, and a lack of anterior teeth.</p>
            <p>Helkimo analysis was done only on the number of patients participated in the study, not on the basis of sex and gender differentiation (both male and female were taken into consideration in the study) to assess the occurrence of TMD in cleft patients.</p>
            <p>In this study on evaluation and comparison with the Helkimo anamnestic index, it was found that 10% of group 1 had no symptoms of TMD (Ai0), which might be due to the absence of crowding in the anterior arch and the absence of crossbite in both the anterior and posterior, that is, both the upper and lower teeth were coordinated. 40 % reported mild TMD symptoms (Ai1). It could be a sign of the presence of TMJ sounds, jaw stiffness, or jaw tiredness (clicking). These cases might have a lesser fibrosis of muscle fiber, which causes less contraction and relaxation of muscle, which leads to jaw fatigue and stiffness. Muscle stiffness causes a shift in the orientation of the condyle during downward and forward movement of the mandible, resulting in TMJ clicking. Among severe cases (AI 2), 10% had difficulties in mouth opening, which could be suggestive of a decrease in range of mouth opening (normal range &gt; 40 mm) and agenesis of teeth. There were no cases where the patient experienced lockjaw. Furthermore, 10% had mandibular dislocation and painful movements, which might be the result of the presence of crossbite in the posterior and anterior, which leads to severe constriction of the maxillary arch, which changes the orientation of the muscle fiber as well as the orientation of the condyle.</p>
            <p>While 30% of the patients had painful TMJ regions and/or masticatory muscles, which might be due to the presence of grinding and clinching habits, an imbalance in the muscles of mastication caused by excessive teeth grinding is a typical cause of TMJ discomfort.</p>
            <p>When Group 2 were assessed for occurrence of TMD using Helkimo anamnestic index, and 40% of the cases had mild symptom while 60% had no symptoms at all.</p>
            <p>Helkimo dysfunction index evaluation, it was found that 35% of Group 1 had mild symptoms of TMJ dysfunction (Di1), which could be due to pain during mandibular movement while wide opening of the mouth causes stretches in muscle fiber and condylar ligaments. Furthermore, 30% experienced moderate TMD symptoms (Di 2), which were thought to be caused by tenderness in the temporomandibular joint while palpating the lateral side of the TMJ. Pain while performing lateral movements, as well as a wide opening of the mandible. While palpation of masticatory muscles at 1-3 sites (masseter and temporalis muscles) may reveal tenderness as the jaw closes, the upper and lower arches are not in sync. which could lead to the presence of a clicking sound in the TMJ in one joint or both joints.</p>
            <p>35% had a severe symptom of TMD (Di 3), due to the presence of tenderness during palpation of the posterior side of the TMJ. Because the posterior part of the articular disc is made up of nerves and vessels, compression causes TMJ pain. A lack of occlusal harmony in the upper and lower arch causes canine guidance discord and TMJ pain when performing two or more mandibular movements, such as lateral movement of the mandible.</p>
            <p>The prevalence of TMD in Group 2 was evaluated using the Helkimo dysfunction score. Because their jaws were in harmony with crowing less than 2mm, 25% had no symptoms of TMD (Di0). 70% of the 14 cases had a mild symptom of TMD (Di1), which could be due to anterior crowding and a single tooth crossbite. Further, 5% of the patients had moderate TMD symptoms (Di 2), which were assumed to be due to the presence of moderate crowding in the anterior and proclination of the upper and lower anterior teeth, whereas a severe case of TMD was not present.</p>
            <p>In comparison of the Helkimo dysfunction score between two groups (the mean value was calculated for dysfunction). The statistics suggested that the mean of 7.50 was the cumulative result of the assessments done for Ai and Di, suggesting a high occurrence of TMD in Group 1. As for Group 2, the mean of 1.65 indicates that TMD is not common there. Thus, it was found that out of 20 UCLP cases, 7 had mild symptoms, 6 had moderate symptoms, and 7 had severe symptoms, demonstrating that TMD can develop in unilateral cleft lip and palate.</p>
            <p>On evaluation for the dysfunction component of Helkimo, cases with no symptoms of TMD were higher in group 2 in comparison to Group 1. The mild symptom of TMD was also higher in Group 2 in comparison to Group 1. While moderate symptoms of TMD were higher in Group 1 in comparison to Group 2, severe symptoms of TMD were also found to be higher in Group 1 in comparison with Group 2.</p>
            <p>Even the mean dysfunction score in group 1 was higher than in group 2, indicating that craniofacial malformations such as deformity of the jaw, dentition, and soft tissue in cleft lip and palate cases resulting in disfigurement and malocclusion from mild to severe grade can lead to TMDs that must be addressed depending on the severity of the occurrence of TMDs.</p>
        </sec>
        <sec id="sec10" sec-type="conclusion">
            <title>Conclusion</title>
            <p>On evaluation of the anamnestic component and dysfunction component of the Helkimo index, the UCLP group shows higher occurrences of temporomandibular disorder in contrast to the Class I group. However, the severity of TMD was greater among UCLP group.</p>
            <sec id="sec11">
                <title>Limitation</title>
                <p>Patients with only Angle&#x2019;s class I malocclusion were selected in the study. Class II malocclusion tendencies are more common in BCLP cases because premaxillary prominence was pulled back during lip surgery, which causes locking of the jaw, this leads to class II, while UCLP has shown more tendencies for class III as the mandible is free to grow in hypoplastic maxillary conditions. Gender wise correlation of each group was not considered. Growth pattern correlation of each group was not considered. </p>
            </sec>
        </sec>
    </body>
    <back>
        <sec id="sec14" sec-type="data-availability">
            <title>Data availability</title>
            <p>Zenodo: Assessment of Temporomandibular Joint for Occurrence and Severity of Disorders in Adult Cases with Unilateral Cleft Lip and Palate and Non-Cleft Class I Using Helkimo Index. 
                <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.5281/zenodo.7820354">https://doi.org/10.5281/zenodo.7820354</ext-link>.
                <sup>

                    <xref ref-type="bibr" rid="ref13">13</xref>
</sup>
            </p>
            <p>This project contains the following underlying data:
                <list list-type="bullet">
                    <list-item>
                        <label>&#x2022;</label>
                        <p>group 1.csv</p>
                    </list-item>
                    <list-item>
                        <label>&#x2022;</label>
                        <p>group 2.csv</p>
                    </list-item>
                </list>
            </p>
            <p>Data are available under the terms of the 
                <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/legalcode">Creative Commons Attribution 4.0 International license</ext-link> (CC-BY 4.0).</p>
        </sec>
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