| CTRI Number |
CTRI/2025/07/090051 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of Herbal Chewable tablet in Orthodontic patients |
|
Scientific Title of Study
|
Evaluation of Anti plaque effect of a novel herbal chewable tablet containing orange peel and syzygium cumini extract in patients undergoing orthodontic therapy : A Randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Surekha Rathod |
| Designation |
Professor |
| Affiliation |
Rnajeet Deshmukh Dental College, Nagpur |
| Address |
104, dept of periodontology and implantology, Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Surekha Rathod |
| Designation |
Professor |
| Affiliation |
Rnajeet Deshmukh Dental College, Nagpur |
| Address |
104, dept of periodontology and implantology ,
Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Surekha Rathod |
| Designation |
Professor |
| Affiliation |
Rnajeet Deshmukh Dental College, Nagpur |
| Address |
104, Dept of periodontology and implantology, Ranjeet deshmukh dental college and research centre, nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Dept of periodontology and implantology |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| self |
Department of periodontics and implantology |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SUREKHA RATHOD |
Ranjeet deshmukh dental college and research centre |
104, dept of periodontology and implantology
Nagpur
MAHARASHTRA |
09011071477
drsurekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine mouthwash |
0.12% chlorhexidine mouthwash 10ml twice daily |
| Intervention |
Herbal dispersible chewable tablet |
containing orange peel and syzygium cumini extract 10 ml twice daily |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 17-25 years undergoing fixed orthodontic therapy.
2. Patients with no history of systemic diseases affecting oral health.
3. Willingness to comply with study protocol.
4. Patients undergoing fixed orthoodntics
|
|
| ExclusionCriteria |
| Details |
1. History of periodontal therapy in the past 6 months.
2. Known allergies to Citrus or Herbal extracts.
3. Use of antibiotics or anti-inflammatory medications in the past month.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in plaque index scores (Silness and Löe plaque index), Changes in gingival index (Löe and Silness), The Orthodontic Plaque Index(OPI) An oral hygiene index for patients with multibracket appliances. |
0,3,5,12 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reported acceptability and compliance, and any adverse effects. |
12 days |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
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)
|
08/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
The herbal dispersible chewable tablet is expected to demonstrate a significant reduction
in plaque accumulation
compared to chlorhexidine mouthwash. Improved patient compliance due to the
palatability and ease of use of the chewable tablet. Minimal to no side effects
compared to chlorhexidine. The study will provide evidence supporting a natural
and effective alternative for plaque control in orthodontic patients, filling
the existing gap in herbal oral care research.
|