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Comparative evaluation of Chlorhexidine and Triphala with Rajat Bhasma jelly as against Chlorhexidine mouth rinse in prevention of bacterial accumulation in fixed orthodontic assembly: A randomized interventional study

[version 1; peer review: 2 approved with reservations]
PUBLISHED 25 May 2023
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This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background: By offering numerous mechanical retention sites, fixed orthodontic treatment increases the build-up of bacterial plaque, rendering teeth more susceptible to gingivitis and periodontitis.
Chlorhexidine is a frequently utilised adjuvant to mechanical oral hygiene techniques and is regarded as the gold standard. As compared to chemicals and allopathy, nowadays patients are showing great inclination for the herbal products.
Commercially available herbal mouhrinses are emerging in the market. Due to their lack of purity, these is a need for more herbal alternative mouthrinses like Triphala.
As known, silver coated wire has antimicrobial and antiadherent properties, still not commercially available. Some reasons could be cost, toxicity levels, etc. Thereby, to evaluate the effects herbal mouthwashes in adjunct with herbal form of silver i.e. Rajat bhasma, present study has been taken up to check the antimicrobial and anti-adherent properties with various combinations
Objectives:
1. To evaluate the efficacy of chlorhexidine mouthrinse and Rajat bhasma jelly as an antimicrobial agent
2. To evaluate the efficacy of Triphala mouthrinse and Rajat bhasma jelly as an antimicrobial agent
3. To compare the antimicrobial potency of chlorhexidine, triphala with rajat bhasma jelly combinations as against chlorhexidine on bacterial accumulation (streptococcus mutans and lactobacillus).
Methods: Plaque will be collected from the left molar to right molar of the upper arch with a disinfected curette at 3 time periods:
T 0 = just prior bonding, following full prophylaxis.
T 1 = one month following bonding.
T 3 = two months following bonding Streptococcus mutans and lactobacilli will be quantified by colony count procedure.
Expected results: Patients receiving orthodontic treatment experience a greater reduction in plaque buildup attributable to the synergistic effects of rajat bhasma and different mouthrinses.
Conclusion: It is expected that, Rajat bhasma and triphala being ayurvedic products cause no harm and show plaque reduction.
Trial number: CTRI/2022/07/044130

Keywords

Rajat Bhasm, Triphala, Chlorhexidine, Streptoccocus mutans, plaque

Introduction

By providing numerous mechanical retention sites like brackets and wires, fixed orthodontic treatment increases the accumulation of bacterial plaque. Additionally, physiological factors like thick saliva, poor oral hygiene, and difficulty performing oral hygiene procedures due to multiple attachments among orthodontic patients may make them more susceptible for plaque accumulation that causes gingivitis and periodontitis.

The retention of dental plaque is more likely with multibracket orthodontic assembly, making oral hygiene a difficult work for patients.1 Due to the inaccessibility of cleaning the minute areas of these appliances, patients having orthodontic brackets have enamel demineralization risk.2 Oral ecological changes such as plaque may build as a result of increased salivary lactobacilli and streptococcus mutans brought on by orthodontic treatment.3 One of the key colonisers in the multispecies dental biofilm is Streptococcus mutans and lactobacilli.4 During the use of fixed orthodontic appliances, it has been discovered that the number of germs might grow up to five times.4 This imply the need for prophylactic measures against colonization of streptococcus mutans and lactobacilli.4 Orthodontic attachments and bonding materials that plaque and encourage the establishment of “white spot lesions”, increased friction during retraction, decreased desired tooth movement and dental caries as well.5 Streptococcus mutans and Lactobacilli are the most frequent bacteria that cause plaque to form.6

Caries-preventive operations, optimum dental hygiene maintenance, noncariogenic diet, and systematic fluoride supplementation are generally inadequate in preventing demineralization and initiation of new carious lesions in fixed orthodontic appliance therapy in subjects with increased caries susceptibility.3 Direct chemotherapeutic drug suppression of the cariogenic oral microbiome, as well as improved oral hygiene, have been employed as preventive interventions in these vulnerable populations. Using exogenous anti-caries compounds has been shown to be effective for preventing caries, reducing plaque buildup, and demineralization during orthodontic treatment.2

To prevent plaque accumulation and for daily interventions, mouth rinses are used since a long ago (in both herbal, chemical form). However, the reasoning and cautious justification for the use of chemical components have only recently been the focus of scientific study and clinical testing.7

A cationic bisbiguanide with a very wide range of antibacterial action is chlorhexidine, which is frequently used both on its own and as addition to mechanical methods of oral hygiene.8 The main benefit of chlorhexidine is its substantivity, which allows it to bind to both soft and hard tissues in the oral cavity and act for an extended period of time following application of a formulation.8 In our department’s orthodontic clinic, chlorhexidine mouthwash is frequently administered to patients. However, extended use of chlorhexidine is prohibited due to a number of documented negative effects, including tooth discolouration, changed taste perception, increased calculus formation, oral mucosa desquamation.

Dentists work in a time when patients are more concerned with both their oral and overall health and medical well-being with a long-term effect rather than a short term. As compared to chemicals and allopathy, now a days patients are showing great inclination for the herbal products as they have no allergy, no side effects and safe to use with no chemical Ingredients.

Commercially available herbal mouhrinses are emerging these days in the market. But these are not 100% pure. Because of their lack of purity, these is a need for more herbal alternative mouthrinses like Triphala. Herbal medicine offers a preventive and promotional approach to oral health. Scientific research has shown that natural remedies such as Triphala Amalaki, bibitaki, haritaki, Tulsi Patra (Ocimum sanctum), Jyestiamadh (Glycyrrhiza glabra), (Neem Azadirachta Indica), Clove oil (Caryophyllus aromaticus), Pudina (Menthaspicata), Ajwain (Trachyspermum ammi), and Sushruta Samhita’s 20th shloka states that triphala can be used as a mouthwash for dental problems.9

Seldon studies have specifically targeted Streptococcus mutans and lactobacilli for reducing plaque accumulation. In traditional Ayurvedic medicine, “Triphala” is one of the most often employed formulations.

Composed of the fruits of three trees, Indian gooseberry Amalaki (Embilica offi cinalis), Bibhitaki (Terminalia beleria), and Haritaki (Terminalia chebula),

Triphala is a tonic that is prized for its capacity to regulate the digestive and elimination processes. It is made up of the fruits of three different trees: the Indian gooseberry Amalaki (Embilica officinalis), the Bibhitaki (Terminalia beleria), and the Haritaki (Terminalia chebula). Triphala may be used to treat periodontal disorders, according to research by Maurya et al. The effectiveness of triphala mouthwash in reducing the number of Streptococcus counts was examined by Jagtap and Karkera.10

In the theory of friction mechanics, tooth movement is accomplished by guiding or walking a tooth along a continuous arch wire while wearing a bracket. Friction created at the bracket-wire interface limits tooth movement. Silver-coated wire has been shown to have antibacterial and antiadhesive qualities.11 The frictional property of ss wires may be affected by this silver coating. Despite it being an effective antiplaque agent, it is not yet commercially available. Cost, toxicity levels, etc., are only a few of the possible explanations. Therefore, the current study has been undertaken to assess the antibacterial and anti-adherent qualities using various combinations in order to evaluate the effects of herbal mouthwashes in adjunct with herbal form of silver, i.e. Rajat bhasma.12

It was believed that mouthwash, in addition to its other benefits including ease of accessibility and affordability, could be a useful substitute for orthodontic patients. The goal of this study is to compare the anticariogenic efficacy of triphala mouthwash, developed at the Mahatma Gandhi Ayurveda College, Hospital and Research Centre, Datta Meghe Institute of Medical Sciences (DMIMS), with the already well-established chemotherapeutic chlorhexidine.

The goal of the study is to compare the antimicrobial effectiveness of herbal triphala mouthwash, traditional chlorhexidine mouthwash, and commercially available herbal mouthwash in conjunction with Rajat bhasma jelly in patients receiving fixed orthodontic treatment.

Objectives

  • 1. To evaluate the efficacy of chlorhexidine mouthrinse and Rajat bhasma jelly as an antimicrobial agent

  • 2. To evaluate the efficacy of Triphala mouthrinse and Rajat bhasma jelly as an antimicrobial agent

  • 3. To compare the antimicrobial potency of chlorhexidine, triphala with rajat bhasma jelly combinations as against chlorhexidine on bacterial accumulation (streptococcus mutans and lactobacillus).

Methods

This study will be conducted at the Department of Orthodontics and Dentofacial Orthopaedics, SPDC Wardha in collaboration with Department of Microbiology, JNMC, Wardha and Department of Rasashastra and Bhaishajya Kalpana, MGAC, Salod, Maharashtra.

Trial registration number: CTRI/2022/07/044130.

Total 45 patients will be selected. Patients will be selected from OPD and consent will be taken for the participation in the study.

The total cases will be divided into 3 groups:

  • 1. Group I: Chlorhexidine mouthrinse with rajat bhasma jelly

  • 2. Group II: Triphala mouthrinse with rajat bhasma jelly

  • 3. Group III: Distilled water with rajat bhasma jelly

The procedure will be explained at length to the patients. Before the treatment, and during every follow up visits, oral hygiene instructions to be explained to the patients. Verbal directions and physical demonstration will be provided on how to perform the procedure to the patients.

Plaque will be collected from the left molar to right molar of the upper arch with a sterile curette at 3 intervals:

T 0 = just prior bonding, following full prophylaxis.

T 1 = one month following bonding.

T 3 = two months following bonding Streptococcus mutans and lactobacilli will be quantified by colony count procedure.

A. Initial drug preparation of Triphala mouth rinse

  • Raw materials of plant origin will be obtained from Dattatraya Ayurveda Rasashala Sawangi, Wardha.

  • These raw materials will be then identified and authenticated by a taxonomist.

  • Pharmaceutical preparation of Triphala mouth rinse will be conducted at Dattatraya Ayurved Rasashala, Mahatma Gandhi Ayurveda College, Hospital and Research centre, Salod (H) Wardha, Maharashtra.

  • The preparation will be tested for organoleptic characters, physicochemical analysis, and microbial contamination in analytical lab as per API standards.

  • Ingredients of Triphala mouth rinse are depicted as follows:

  • “Haritaki” (“Terminalia Chebula Retz”): Fruit pulp-1 part (astringent and laxative)

  • “Bibhitaki” (“Terminalia Belerica Roxb”): Fruit pulp1 part (laxative)

  • “Amalaki” (“Emblica officinalis Gaertn”): Fruit pulp1 part (anti-inflammatory)

  • Water for decoction: 16 parts

  • Alcohol (Ethanol): 5%(disinfectant)

  • Menthol (Peppermint): 0.042%(flavoring agent)

  • Thymol (Thymus vulgaris): 0.064%(fungicide)

Preparation of Triphala mouth rinse

  • The procedure of Kwatha kalpana will be followed for the preparation of Triphala mouth rinse.

  • All the above-mentioned raw ingredients will be coarsely powdered, weighed individually, and then amalgamated together meticulously.

  • This amalgamation will be diluted 16 times by addition of distilled water, and boiled in a steel vessel at 90-100° C temperature till the solution gets reduced to 1/4th of its original volume.

  • Throughout the procedure, the solution will be continuously stirred.

  • The decoction will be then sieved through a piece of cloth.

  • 5% alcohol, 0.042% Menthol and 0.064% Thymol will be added and mixed with a stirrer to get a homogenous liquid.

  • Finally, it will be filled in 200 ml amber-coloured plastic bottles and packed with air tight lid.

B. Preparation of Rajat bhasma jelly

  • 125 mg of Rajat bhasma powder to be mixed with 1 table spoon of ghee.

  • 1 table spoon is approximately 7.6 ml

  • Jelly consistency to be formed and stored in plastic containers in refrigerators.

Methods

  • Plaque will be gathered from the buccal surface of maxillary teeth (molar to molar) between the bracket and the gingival surface with the use of disinfected curette, before bonding after complete prophylaxis, to govern the patient’s cart of Streptococcus Mutans and Lactobacilli, which will be referred to as T0. A chosen region of the anterior dentition will be isolated with cotton rolls for swab collection.

  • The appliance bonding procedures will be then carried out.

  • Patients will be given instructions about how to use the mouth rinse and the application of Rajat bhasma jelly and a checklist, in the form of an instruction chart, for the purpose of making them adhere to the guidelines of the study and to maintain a level of stringency while following oral hygiene protocol.

  • Following the collection of samples for T0, patients will be instructed to maintain oral hygiene by using mouthwash and rajat bhasma jelly, and they will be divided into three groups at random (simple random sampling in the ratio of 1:1:1).

  • The three groups will be based on the different mouth rinse with rajat bhasma jelly being used by the patient.

  • Group I: Chlorhexidine mouthrinse with rajat bhasma jelly

  • Group II: Triphala mouthrinse with rajat bhasma jelly

  • Group III: Distilled water with rajat bhasma jelly

  • 2nd reading termed T1 will be taken 1month after bonding procedure.

  • These results will be compared to T0 to see if there is a difference in streptococcus mutans and lactobacilli colonisation installation of permanent appliances both before and after.

  • Next reading will be taken 2 months after bonding procedure. Samples will be collected again, and the readings will be termed as T2.

T0, T1 and T2 readings will be compared to one another using the proper statistical techniques, and the variation in S. Mutans and lactobacilli colonisation at each interval will be noted in order to reach a conclusion evaluating the synergistic effect of each of the aforementioned mouthwashes with rajat bhasma jelly.

Procedure for sample collection and testing

  • The amount of S. Mutans will be quantified by colony count procedures in Microbiology lab in JNMC.

  • Plaque samples will be collected in a dry area using a sterile curette, then placed in a test tube with 2 ml of transport fluid (brainheart infusion broth), and transferred within 2 hours to the microbiology lab for processing.

  • After that, S. Mutans and Lactobacilli will be identified by plating samples on blood agar.

  • Streaking will be carried out using sterile, 4mm-diameter nichrome loops.

Trial design

Randomized, Parallel, Multiple arm, allocated in the ratio of 1:1:1 in superiority framework

Inclusion criteria

  • 1. Patients with aligned arches irrespective of the type of molar relation requiring fixed orthodontic treatment in the departmental OPD.

  • 2. Using edgewise brackets that have already been modified for patients.

  • 3. Patients in which lig-o-rings will be used to secure the wire in the brackets.

  • 4. Patient who donot show any history of hypersensitivity with the materials that are used for the study like metal allergy based on the clinical history.

  • 5. Age group of 15-25 years will be included in the study.

Exclusion criteria

  • 1. Patients with gingivitis and periodontitis.

  • 2. Patients who have undergone orthodontic treatment more than 1 month.

  • 3. Patients undergoing orthodontic treatment with lingual, self-ligating brackets or myofunctional appliances.

  • 4. Patients with cleft lip and palate and other dentofacial anomalies.

  • 5. Syndrome patients that are unable to practise good dental hygiene.

  • 6. Patients with dental crowding as crowding will require more time to reach to 16×22” wire and also crowded arch will have more plaque than aligned arches.

  • 7. Patients with very short clinical crown or patient started when the teeth are in erupting Phase.

For terminating or changing the prescribed therapies for a specific research participant, two requirements must be met: the presence of dangers or participant request.

Outcomes:

Primary: reduction in plaque accumulation.

Sample size calculation

This is an in-vivo, randomized, parallel, multiple arm type of study.

We are using Rajat Bhasma jelly for our study and so no such type of study has been done before using the same.

So by using the convenient non-random sampling method, we will be collecting the sample from our Departmental OPD during the period of 1.5 years.

Total number of groups to be studied = 3.

Therefore, total sample size = 3×15 = 45.

So, three samples are to be collected from each patient = 3×15 = 45.

The procedure will be explained to and educated upon by the patients. All 45 patients will be asked for written consent that has been fully informed.

According to the study’s goals, participants from the departmental OPD who were recommended for treatment with a fixed stainless steel preadjusted edgewise appliance would be divided into 3 groups with 15 participants in each group at a ratio of 1:1:1.

  • Group I: Chlorhexidine mouthrinse with rajat bhasma jelly

  • Group II: Triphala mouthrinse with rajat bhasma jelly

  • Group III: Chlorhexidine mouthrinse

All patients will be first sent for oral prophylaxis after which the 1st reading will be collected.

Recruitment: Techniques for increasing participant enrollment to the desired sample size.

Dissemination

Via publication.

Plaque accumulation causes friction in orthodontic brackets which interfere with the treatment, so by the use of these ayurvedic products, which will cause no harm to the overall health of the patient (unlike other products available in the market) plaque accumulation can be reduced. Also, these products are more economic.

Study status

Not started.

Ethical considerations

Research ethics approval: Institutional ethics committee Approved.

Consent or assent: Informed and written both type of consent will be taken from the patients.

Confidentiality: To guarantee confidentiality before, during, and after the trial, personal information regarding enrolled and prospective participants will be gathered, exchanged, and maintained.

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AGARWAL N, Daigavane P and Kamble R. Comparative evaluation of Chlorhexidine and Triphala with Rajat Bhasma jelly as against Chlorhexidine mouth rinse in prevention of bacterial accumulation in fixed orthodontic assembly: A randomized interventional study [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:548 (https://doi.org/10.12688/f1000research.133532.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 25 May 2023
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Reviewer Report 24 Nov 2023
Péter Vályi, Semmelweis University, Budapest, Budapest, Hungary 
Approved with Reservations
VIEWS 4
This study protocol meet with requirement of publishing, but some correction is needed:

„By providing numerous mechanical retention sites like brackets and wires, fixed orthodontic treatment increases the accumulation of bacterial plaque. Additionally, physiological factors like thick ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Vályi P. Reviewer Report For: Comparative evaluation of Chlorhexidine and Triphala with Rajat Bhasma jelly as against Chlorhexidine mouth rinse in prevention of bacterial accumulation in fixed orthodontic assembly: A randomized interventional study [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:548 (https://doi.org/10.5256/f1000research.146528.r217740)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
Views
6
Cite
Reviewer Report 14 Nov 2023
Sangeeta Nayak, Department of Periodontology, Manipal College of Dental Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India 
Approved with Reservations
VIEWS 6
  1. Study aim and objectives need to be specified.
     
  2. Methodology needs clarification - whether CHX and Tripala was used separately or or as a single product with rajat bhasma. patient usage instructions are
... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Nayak S. Reviewer Report For: Comparative evaluation of Chlorhexidine and Triphala with Rajat Bhasma jelly as against Chlorhexidine mouth rinse in prevention of bacterial accumulation in fixed orthodontic assembly: A randomized interventional study [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:548 (https://doi.org/10.5256/f1000research.146528.r197710)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 25 May 2023
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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