| CTRI Number |
CTRI/2025/10/096582 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the efficacy of ayurvedic extracts in preventing post-orthodontic relapse |
|
Scientific Title of Study
|
Evaluating the efficacy of Herbal extracts in preventing post-orthodontic relapse |
| Trial Acronym |
Herb-Relapse |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravinkumar |
| Designation |
PhD scholar |
| Affiliation |
CSMSS DENTAL COLLEGE AND HOSPITAL |
| Address |
CSMSS Dental College and Hospital Department of Orthodontics Room no 7 Kanchanwadi Paithan Road Chhatrapati Sambhajinagar, Maharashtra 431011
CSMSS Dental College and Hospital Department of Orthodontics Room no 7 Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Maharashtra 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9404366634 |
| Fax |
|
| Email |
drpravinkumar08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suchita Tarvade(Daokar) |
| Designation |
Professor and Head |
| Affiliation |
CSMSS DENTAL COLLEGE AND HOSPITAL |
| Address |
CSMSS Dental College and Hospital Department of orthodontics room no 7 KanchanwadiPaithan Road Chhatrapati Sambhajinagar Maharashtra 431011
CSMSS Dental College and Hospital department of orthodontics room no 7 KanchanwadiPaithan Road Chhatrapati Sambhajinagar Maharashtra 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9822523556 |
| Fax |
|
| Email |
suchitadaokar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravinkumar S Maroore |
| Designation |
PhD scholar |
| Affiliation |
CSMSS DENTAL COLLEGE AND HOSPITAL |
| Address |
CSMSS Dental College and Hospital Department of orthodontics room no 7 KanchanwadiPaithan Road Chhatrapati Sambhajinagar Maharashtra 431011
CSMSS Dental College and Hospital Department of orthodontics room no 7 KanchanwadiPaithan Road Chhatrapati Sambhajinagar Maharashtra 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9404366634 |
| Fax |
|
| Email |
drpravinkumar08@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Dental College and Hospital Chhtrapati sambhajinagar Maharashtra India 431002 |
|
|
Primary Sponsor
|
| Name |
DR PRAVINKUMAR MAROORE |
| Address |
CSMSS Dental College and Hospital KanchanwadiPaithan Road Chhatrapati Sambhajinagar Maharashtra 431011 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Pravinkumar S Maroore |
CSMSS Dental College and Hospital |
Department of orthodontics room no 7 KanchanwadiPaithan Road Chhatrapati Sambhajinagar Maharashtra India 431011
Aurangabad
MAHARASHTRA |
09404366634
drpravinkumar08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHARASHTRA INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE LATUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
in patients with On going orthodontic treatment of all upper and lower teeth except second and third molars |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: placebo , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: no medication group | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Herbal Extract Capsules (Cissus quadrangularis, Glycyrrhiza glabra, Terminalia chebula, Terminalia arjuna, etc, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: Start immediately after removal of main archwire/ligature wires (post-stabilization). |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 15 to 28 years.
2. Patient with erupted all permanent teeth except 3rd molars
3. Patient with good general health.
4. Patients voluntarily involved in the study.
5. Patients having skeletal class I and dental class I with moderate to severe crowing and/or spacing.
|
|
| ExclusionCriteria |
| Details |
1. Patients with syndromes or systemic diseases (Diabetes or any bone disorders)
2. Patients in pregnancy.
3. Patients with allergic to any ingredients in the herbal products.
4. Patients with multiple prosthesis.
5. Patients with periodontally compromised teeth.
6. Patients taking any nutrition supplements or drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of herbal extract on the stability of orthodontic treated patients. |
Baseline (Day 0;after archwire removal), and after 3 months (±14 days). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of herbal extracts on gingival health in orthodontically treated patients |
Baseline (Day 0;after archwire removal), and after 3 months (±14 days). |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drpravinkumar08@gmail.com].
- For how long will this data be available start date provided 20-10-2025 and end date provided 02-01-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This randomized controlled clinical trial is designed to evaluate the efficacy of selected herbal extracts in preventing post-orthodontic relapse among patients with Class I malocclusion who have completed fixed orthodontic treatment. A total of 52 participants aged 15–28 years, meeting the inclusion and exclusion criteria, will be randomly allocated into intervention and control groups. The intervention group will receive herbal extract–based formulations in addition to standard retention protocol, while the control group will receive standard retention protocol alone. The primary outcome will be reduction in post-treatment relapse measured by Little’s Irregularity Index at baseline, 1 and 3 months. Secondary outcomes will include changes in gingival index and patient-reported comfort and compliance. Safety outcomes and adverse events will also be monitored at each follow-up visit. This study will provide preliminary clinical evidence on the role of herbal extracts as a supportive adjunct in orthodontic retention and relapse prevention. |