[version 2; peer review: 1 approved, 1 approved with reservations, 1 not approved]
No competing interests were disclosed.
Sushruta (600 B.C.) described a condition called “Vidari” linked with progressive narrowing of mouth, depigmentation of the oral mucosa, and pain on taking food, oral submucous fibrosis (OSMF). With an overall Indian prevalence rate of between 0.2–0.5%, OSMF is primarily found in India and Southeast Asia, according to global estimations. Patients with OSMF need regular follow-ups and to maintain this follow-up it is not always possible for the patient to visit a dental clinic. Hence developing a smartphone-based application for the follow-up of OSMF will be of great value to the patients. The study aims to evaluate the effectiveness of a smartphone application on OSMF self-examination in the follow-up of patients.
There will be three phases of the research. The first phase will be the development of a smartphone-based application for the follow-up of patients with OSMF. The second phase will be distribution and training the patients regarding the usage of the application and the third phase will be evaluating the effectiveness of the smartphone application in maintaining the follow-up of the patients.
The follow-up of patients with OSMF is expected to be better and feasible using a smartphone application as compared to regular Outpatient Department-based follow-up.
Designing a mobile application for the ease of users presents difficulties since it must take user-friendliness and accessibility into account, which influences how well the application is received by users. In addition to follow-up, the smartphone-based application promotes the awareness towards Self-examination and knowledge in OSMF patients. Thus, it will act as an educational tool providing information, to enhance OSMF screening practice.
CTRI/2023/06/054514 (registration pending).
The revised version of the article has explained the phases of the study along with the timeline and medical intervention, while follow-ups are added to the methodology of the article. In addition, the article has clarified the patient outcome, generalizability, and effectiveness of smartphone applications in augmenting patient compliance, follow-up, and awareness towards self-examination in OSMF screening. Thus, a defined timeline of all the phases has been added to the manuscript. The modifications in the smartphone application will be done according to feedback on the patient's understandability and usability regarding the self-assessment of any parameter of OSMF. To assess the effectiveness of the intervention being tested, the authenticity and reliability of the self-assessment findings will be cross-checked in 15 participants of the intervention group. These 15 patients will be called in OPD, and the submitted data of these patients through a smartphone app and observations on physical examination will be compared. A new author was added to the paper for their contributions.
The World Health Organization (WHO) described this condition as “a slowly progressing disease in which fibrous bands form in the oral mucosa, ultimately leading to the severe restriction of movement of the mouth including tongue” in 1978.
According to estimates, 7–30% of oral submucous fibrosis (OSMF) cases will develop into oral squamous cell carcinoma (OSCC).
OSMF is closely linked with the use of betel nut/areca nut, which is classified as grade I hazard by WHO. The use of betelnut is very common in the Indian population being part of cultural events. The betelnut and its products are easily accessible.
The oral mucosa of patients with the condition has a leathery feel and perceptible vertical fibrous bands, which finally restricts mouth opening and makes the tongue hard. Early signs of the condition include a burning feeling when eating spicy food, losing normal pigmentation, and blanching of the mucosa. Ulcers, dry mouth, burning in the mouth, and restricted mouth opening are some of the clinical symptoms of OSMF.
A mobile application containing material that is specifically designed for end users, such as the general public, may increase the intervention’s acceptability and effectiveness. The creation of mobile applications that incorporate theory may emphasize and support behavior modification for health promotion in patients with OSMF.
To develop evidence based relevant content for the development of a user-friendly self-assessment smartphone application for patients with OSMF.
To train and counsel patients regarding the utilization of the smartphone application. To modify the application as per the requirement and suggestions of the user.
To assess the efficacy of smartphone self-assessment application in maintaining the follow-up of the patients.
Ethical approval has been received from Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha IEC reference number DMIHER (DU)/2023/568. Consent from the intervention group will be taken using electronic consent forms. For the routine outpatient department (OPD)-based follow-up, written consent form will be taken manually. This clinical trial study protocol adhered to the SPIRIT checklist.
This prospective study will be conducted at Sharad Pawar Dental College, Sawangi (Meghe), Wardha in the Dept. of Oral Medicine and Radiology.
After getting ethical approval from “The Institutional Ethics Committee (IEC)” of Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, for this study, the patients who will be clinically diagnosed with OSMF will be recruited in the study. The participants will be selected as per the inclusions and exclusions given in the criteria.
All the recruited participants will be divided into two groups: control group (OPD-based follow-up) and the intervention group (smartphone-based follow-up). The control group will be monitored by the conventional follow-up method of assessment in patients with OSMF, and the intervention group will be monitored using the smartphone application for the follow-up of the patients. Depending on the findings of the two comparative groups, the efficacy of the smartphone application will be assessed in maintaining the follow-up of the patients with OSMF.
The investigator will perform the intervention with the following inclusion and exclusion criteria.
Patients habitual to betelnut chewing (more than six months duration). Patients clinically diagnosed with OSMF. Patients having an acceptable literacy level (
Patients having access to smartphones. Patients who agreed to provide electronic informed consent for the study.
Patients who refuse to consent to participate in the study will not be included. Patients having malignant lesions are also excluded from the study. Patients who are unable to read the application’s teaching materials on their smartphones. Patients who are unable to use the smartphone application efficiently. Patients who presented with congenital or developmental abnormalities of jaw. Patients with post-surgical defect of jaw.
The participants of the intervention group will be given access to smartphone application for the follow-up of the OSMF. Whereas the control group will not be given access to the application. The participants in the control group will be referred to the OPD for the follow-up of OSMF.
The intervention will be accustomed for six months. The initial two months will be the training period for the participants for the usage and various features of the smartphone application. The smartphone application will also be surveyed for any modifications in the smartphone application.
The smartphone application will contain monthly and weekly follow-ups for the users and information regarding the disease and ill-effects of the use of betelnut and its products. After downloading the application, the user will have to fill the demographic details for the sign-in of the application. After the sign-in, the user will have access to follow-up section and the information available on the smartphone application. The user can follow the steps and answer the questions of the follow-up for the monthly and weekly follow-up.
To improve the adherence of the participants in the intervention group, the smartphone application will have a feature of notification reminder to adhere to the follow-up of OSMF on weekly and monthly basis.
All the participants of the control and intervention group will be provided with the medicinal treatment over a period of 6 months. As all the participants are recruited from the OPD-setup, the participants will be examined and will be provided with medicinal treatment depending on their grades or severity of OSMF. Also, all the participants of the intervention group will be in contact with the investigator through telephonic communication. As the main objective of the smartphone application is maintaining long-term follow-ups and patients compliance, more emphasis is given on regular follow-ups.
The outcomes of the study will be measured in terms of augmented patient compliance and regular follow-up of the patients who have OSMF or have the habit of betel-nut chewing. In addition, the smartphone application will be of help in increasing awareness and promoting self assessment in OSMF patients. The participants can adhere to the follow-up more efficiently using the smartphone application for the follow-up and inspect for the improvement of the signs of OSMF on their own. It may not be always feasible for the patients to travel and report the OPD-setup for every-follow-up. Many patients residein the remote regions which are very far from the OPD-setups. Moreover, the patients must maintain long term follow-ups for OSMF, as it has high rate of malignant transformation. Development of such smartphone applications would be very beneficial in maintaining patient compliance and long-term follow-ups of patients.
After introducing the participants of the intervention group to the smartphone application, they will perform the weekly and monthly follow-ups for a period of 6 months.
Significance level Type I error rate, α = 0.05 Power (1-beta) = 0.8 Z alpha value = at 90% 1.645 Z beta value = at 80% 0.842 Expected population standard deviation, SD = 1.5
α err prob = 0.05
Power (1-β err prob) = 0.95
Df = 80
Total sample size = 110
All the patients visiting the out-patient department (OPD) will be thoroughly inspected for the habit of betelnut chewing and clinically diagnosed with OSMF will be recruited. The participants of the intervention group will be introduced to the developed smartphone application for the follow-up. They will be explained about the efficacy of the use of the application for the follow-up of the habit and OSMF which will also help them to cease the habit. Whereas, the participants of the control group will report to the OPD for every follow-up visit.
Sequence generation for both the groups will be done using simple randomization.
The mechanism of implementing the allocation sequence is by sequential numbering.
The investigator will generate the allocation sequence, enroll the participants, and will assign the participants to intervention and the control group.
The participants belonging to both, intervention and control groups will be blinded.
The evidence-based informational materials on OSMF, cancer prevention, and self-examination will be taken from reliable sources such as articles published in indexed journals i.e. scopus, pubmed and web of sciences.
The resources will then be created using Android Studio, a software development environment for the Android platform, in the form of installable applications for mobile devices.
The application will be multilingual.
The OSMF application will consist of two components: the OSMF self-assessment and the OSMF educational resources.
The participants’ smart electronic devices will have the application downloaded, and it can be utilized online. Patients will also be trained by the researcher for the handling of the application. It should be noted that an internet connection will be necessary for the application’s installation.
The piloting of the validated self-examination questionnaire will be done by giving to 10 OSMF patients as a trial prior to the study to check the feasibility and understanding of the questionnaire.
The main objective of this phase is to train and counsel patients regarding the utilization of the smartphone application and to modify the application as per the requirements and suggestions of the participants.
The goals and methods of the study will be explained to each participant. The participants will be made made aware that they need internet access to use the developed smartphone application for OSMF. After installation of the application on their Android phone, which will be made available on Google Play Store, electronically generated informed.
Consent popped up. Only after accepting the consent, the participants will have access to the smartphone application. Concerns over the privacy of personal information will be reassured. The participants will fill their basic demographic details for the sign-in of the app, which will create a unique username and password for all the participants. The participants will also have an option to change their username and password according to their will whenever required. The participants will be trained and made acquainted on how to use the application for the follow-up of the habit and OSMF and its features. After introducing the participants of the intervention group to the smartphone application, they will perform weekly and monthly follow-ups for 6 months. After a month of using the smartphone application regularly, the verbal feedback will be obtained from each participant in case they need any changes or issues with the app or its understandability. Participants will be requested to get in touch with the researcher in case any issues or concerns about using the application.
The data of the participants using the self-examination smartphone application for OSMF follow-up who belong to the intervention group will be stored in the application, which can be accessed by the investigator through an account created in the same smartphone application. The developed smartphone application will have provision that no other person except the investigator will be able to login into that account which receives patient-related data.
The data generated from application will be used to assess: i) Patient compliance; ii) modifications in symptoms; and iii) analysis of patient feedback will be done.
The participants of the control group, who will not be given access to the smartphone application, will be referred to the OPD for the follow-up of OSMF. A proforma will be designed that includes personal details of the participants along with the clinical oral examination for 6-month follow-up.
All the collected data of the patients from either the control or intervention will be converted into a tabulated form, and statistical analysis of the data will be performed. For the maintenance of the data quality, once the data will be collected from the control and intervention group participants, it will be cross-checked by all the investigators. To confirm the authenticity and reliability of the data from the smartphone app, for 15 participants of the intervention group the submitted data of the patients will be cross-checked by examining the patients in the OPD on physical mode. The comparative analysis will be done statistically.
The data will be collected from the patients for follow-up of OSMF visiting OPD for the control group. The data of the participants using the self-assessment smartphone application for OSMF follow-up who belongs to the intervention group will be stored in the application which can be accessed by the investigator. The data collected includes demographic details such as age, address, and contact details. Data will also be collected from the questionnaire of the self-assessment application for OSMF follow-up over a period of six months.
The participants will get regular reminder notifications on their smartphone application which they will be using for the follow-up of OSMF, which will improve participant retention. This will also ensure complete follow-up of the participants of the intervention group.
For the maintenance of the data quality, once the data is collected from the participants of the control and intervention group it will be cross-checked by all the investigators.
Statistical analysis will be done by using descriptive and inferential statistics using Chisquare test, and Student’s paired and unpaired t-test. Interobserver reliability score will be done by Cronbach alpha test and kappa test. Software used in the analysis is SPSS 27.0 version and Graph Pad Prism 7.0 version and p<0.05 is considered as a level of significance.
Not yet started.
The follow-up of the OSMF patients is expected to be better using a smartphone application as compared to the regular OPD-based follow-up. Numerous studies on these applications have been carried out, and more than 40,000 mobile health applications are already accessible on several platforms. However, there isn’t enough research to prove that these mobile apps integrate theory and were created using a qualitative design process. However, as mobile health technologies advance, there is growing concerned about how mobile application performance is constrained by their usability, accuracy, and data privacy.
Rêgo
Chang
The OSMF self-examination awareness approach using Smartphone application involves inspecting and palpating one’s oral mucosa or oral cavity periodically in order to become familiar with it and spot anomalies. The goal of OSMF examination awareness facilitation and intervention is to raise public knowledge. Educational activities significantly contribute to the advancement of information, convictions, and OSMF screening practice.
The adverse habits such as consumption of betelnut chewing and tobacco chewing are prevalent in Indian population, consequently prevention and development of oral potentially malignant disorders such as OSMF is of concern. The population that consumes betel nut and tobacco products is the main focus of the study. The consumption of betel nut and tobacco products is done by a vast number of the Indian population. It is not always feasible for the patients to visit a dental setup for maintaining the follow-up. The study will be helpful in the follow-up of OSMF patients more promptly as well as in awareness towards self-examination.
The study will be published in PubMed, Scopus, and Web of Sciences journal.
No data are associated with this article.
Zenodo: SPIRIT checklist for ‘Comparative evaluation of efficacy of a smartphone application for oral submucous fibrosis (OSMF) self-examination in follow-up of the patients compared to routine Outpatient Department-based follow-up’.
Data are available under the terms of the
I would like to acknowledge the financial support of ICMR PG thesis programme (reference number: MD22DEC-0115). I would like to thank my institute and my colleagues.
The concept of the study is very sound that the patients will be monitored using the smartphone. It can improve patient compliance, enable remote monitoring, and support early intervention, ultimately reducing the disease burden and preventing malignant transformation.
While India has seen rapid growth in mobile technology, recent surveys suggest:
The use of Smartphone still uneven in our population —higher in urban areas, lower in rural. Elderly patients may have very limited digital literacy and those from lower socioeconomic strata may not own smartphones
The other important point is that the monitoring features includes only timely follow-up and educational features. There should have been a wider range of symptoms that can be monitored using the app.
Is the study design appropriate for the research question?
Partly
Is the rationale for, and objectives of, the study clearly described?
Yes
Are sufficient details of the methods provided to allow replication by others?
Partly
Are the datasets clearly presented in a useable and accessible format?
Partly
Reviewer Expertise:
Oral potentially malignant disorders, Oral cancer, Stem cells, Biomaterial research
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
Thank you, mam for your suggestions that could be inculcated into the study
The manuscript has been revised by the authors as per the comments and suggestions.
Is the study design appropriate for the research question?
Yes
Is the rationale for, and objectives of, the study clearly described?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Yes
Reviewer Expertise:
As an Oral Physician I understand the epidemiology, clinical presentation and molecular pathogenesis of the disease studied in the present article.
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.
Thank you sir for approving this version
The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process. This information is critical to assessing the effectiveness of the smartphone application for patients with OSMF. In addition, the protocol doesn't provide adequate information on how participants' privacy will be protected, particularly with regard to the protection of their personal health data. This is a critical issue in mobile health research. The study also lacks a clear definition of how the application will affect patient outcomes, leaving questions about its practical relevance unanswered. The sample size calculation is overly complicated and difficult to verify. The study also does not include a well-defined timeline or feasibility analysis for the phases of the study, in particular how the application will be modified based on user feedback. Without clear results, it is impossible to assess the effectiveness of the intervention being tested.
I recommend not indexing of the study protocol due to significant gaps in methodology, ethical considerations and feasibility.
Is the study design appropriate for the research question?
No
Is the rationale for, and objectives of, the study clearly described?
No
Are sufficient details of the methods provided to allow replication by others?
No
Are the datasets clearly presented in a useable and accessible format?
No
Reviewer Expertise:
smart phone technologies. digital dentistry applications
I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.
The protocol raises several important concerns. One important issue is the lack of clarity about whether medical management or clinical interventions will be part of the follow-up process.
- Yes, all the participants of Control (OPD-based follow-up) and intervention group (smartphone application-based follow-up) will be provided with medicinal treatment or clinical intervention. For both groups, patients will be recruited from outpatient department, the treatment protocol will be explained and medications will be prescribed at first visit.
In control group, as the patients report to the OPD for every follow-up, the participants are examined and medicinal treatment is provided to them depending on their grades or severity of OSMF. For intervention group, the follow-up information of the participants is recorded via smartphone application as well as participants will be in contact with the researcher through telephonic network. The medicinal intervention to the participants of intervention group will be done through telephonic communication.
This information is critical to assessing the effectiveness of the smartphone application for patients with OSMF. In addition, the protocol doesn't provide adequate information on how participants' privacy will be protected, particularly with regard to the protection of their personal health data. This is a critical issue in mobile health research.
- All the data of the participants in intervention group will reach the investigator through an account created in the same smartphone application for which only the investigator has access. No other person is able to login into the account in smartphone app of patient related data other than the investigator.
The study also lacks a clear definition of how the application will affect patient outcomes, leaving questions about its practical relevance unanswered.
-As OSMF is a chronic disease which needs regular and long-term follow-up and patient compliance due to its high malignant transformation rate, development of such smartphone application can be beneficial in maintaining the follow-up in the patients who are unable to report to OPD for follow-up.
The sample size calculation is overly complicated and difficult to verify.
The sample size formula has been edited and simplified in consultation with statistician.
The study also does not include a well-defined timeline or feasibility analysis for the phases of the study, in particular how the application will be modified based on user feedback. Without clear results, it is impossible to assess the effectiveness of the intervention being tested.
- Defined timeline of all the phases have been added to manuscript. The modifications in the smartphone application will be done according feedback on the patients understandability and usability regarding the self-assessment of any parameter of OSMF. To assess the effectiveness of the intervention being tested, the authenticity and reliability of the self-assessment finding will be cross-checked in 15 participants of the intervention group. These 15 patients will be called in OPD and the submitted data of these patients through smartphone app and observations on physical examination will be compared.
The article is well written and elaborates materials and method.
Authors need to explain about follow up wherein only counselling and discontinuation of the habit will be included or any medical management will be employed? As chances of loss of follow up in conventional method will increase if no medical intervention is done.
Is the study design appropriate for the research question?
Yes
Is the rationale for, and objectives of, the study clearly described?
Yes
Are sufficient details of the methods provided to allow replication by others?
Yes
Are the datasets clearly presented in a useable and accessible format?
Yes
Reviewer Expertise:
As an Oral Physician I understand the epidemiology, clinical presentation and molecular pathogenesis of the disease studied in the present article.
I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.
During the follow-up of the participants with OSMF, counseling, discontinuation of habit as well as medical intervention will be provided.