| CTRI Number |
CTRI/2025/06/088712 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can Messaging Apps Boost Braces Compliance? A Study on Oral Hygiene in Orthodontic Patients |
|
Scientific Title of Study
|
Effect of using a messaging app
on improving oral hygiene and compliance in orthodontic patients: A randomized control
study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veeravalli Sai Sandeep |
| Designation |
First year Postgraduate |
| Affiliation |
Manipal college of Dental Sciences |
| Address |
Department of Orthodontics & dentofacial orthopedics Manipal college of Dental Sciences Manipal academy of Higher Education Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8639245709 |
| Fax |
|
| Email |
veeravallisaisandeep0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ramya Vijeta Jathanna |
| Designation |
Associate professor |
| Affiliation |
Manipal college of Dental Sciences |
| Address |
Department of Orthodontics & dentofacial orthopedics Manipal college of Dental Sciences Manipal academy of Higher Education Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9740842366 |
| Fax |
|
| Email |
ramya.jathanna@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veeravalli Sai Sandeep |
| Designation |
First year Postgraduate |
| Affiliation |
Manipal college of Dental Sciences |
| Address |
Department of Orthodontics & dentofacial orthopedics Manipal college of Dental Sciences Manipal academy of Higher Education Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8639245709 |
| Fax |
|
| Email |
veeravallisaisandeep0@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopedics, Manipal
College of Dental Sciences, Manipal Academy of Higher Education, Karnataka, Manipal, 576104,
India. |
|
|
Primary Sponsor
|
| Name |
Dr. Veeravalli Sai Sandeep |
| Address |
Department of Orthodontics & dentofacial orthopedics , Manipal college of Dental Sciences, Manipal academy of Higher Education, Manipal- 576104 |
| Type of Sponsor |
Other [individual] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramya Vijeta Jathanna |
MANIPAL COLLEGE OF DENTAL SCIENCES,MANIPAL |
Department of Orthodontics & dentofacial orthopedics,Room no 7 , Manipal- 576104
Udupi
KARNATAKA |
9740842366
ramya.jathanna@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PATIENTS SEEKING ORTHODONTIC TREATMENT |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NO REMINDER APPLICATION |
The conventional-care-only control group will receive verbal oral hygiene instructions verbally during their routine orthodontic visit |
| Intervention |
WHATSAPP APPLICATION |
WhatsApp app is used since it’s already widely available, easy to use, and familiar to most users.Oral hygiene instructions and multimedia content containing demonstrating brushing techniques are sent to patients
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
adolescents or adults of age group 12-26 years admitted for orthodontic treatment having access to a mobile phone
orthodontic treatment with fixed appliance and single-phase treatment ,
non extraction treatment,
• no previous orthodontic treatment,
• no chronic usage of analgesic medications,
• no previous pain-related pathology or disease,
• Patients with permanent dentition
|
|
| ExclusionCriteria |
| Details |
did not use smartphone that could install WhatsApp
preferred lingual or invisible bracket less technique.
were planned for a multiphase treatment, like combined orthodontic-orthognathic treatment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome measures of the study were improvements in oral
hygiene compliance among orthodontic patients, assessed through plaque index (PI) and
gingival index (GI) demonstrating the effectiveness of reminders in enhancing oral hygiene
compliance. |
at baseline(T0) (before bonding),1 month(T1) And 6 months(T2). |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Several studies have explored the role of digital communication technologies, such as text messages and mobile apps, in improving patient compliance and treatment outcomes in healthcare and orthodontics. Research highlights that timely reminders can significantly enhance attendance, adherence to treatment protocols, and self-care behaviors. For instance, mobile-based systems have proven effective in managing chronic conditions like hypertension and HIV, showcasing their potential in patient education and engagement. In orthodontics, the use of short message services (SMS) and apps like WeChat,WHATSAPP has shown promise in improving oral hygiene, reducing missed appointments, and shortening the duration of treatment. Text reminders and educational content have been reported to positively influence patients’ adherence to oral hygiene practices and reduce orthodontic treatment complications, such as bracket bond failures. However, while some studies have demonstrated improved outcomes with these interventions, others emphasize the need for skill-based training in addition to reminders to achieve sustainable behavioral changes. This growing body of evidence underscores the importance of integrating digital tools in orthodontic practice to enhance patient compliance and overall treatment efficiency. |