| CTRI Number |
CTRI/2025/10/095678 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Herbal Mouthwash on Gum Health in Diabetes |
|
Scientific Title of Study
|
Evaluation of effect of Syzygium cumini and orange peel Mouthwash on Periodontal Health in Type 2 Diabetes Mellitus Patients A Randomized Controlled Trial |
| 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 SUREKHA RATHOD |
| Designation |
Professor |
| Affiliation |
Rnajeet Deshmukh Dental College, Nagpur |
| Address |
Department of Periodontics, 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 |
Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre
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 |
Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre
MAHARASHTRA
440019
India |
| Phone |
09011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet deshmukh dental college and research centre digdoh hills 440019 |
|
|
Primary Sponsor
|
| Name |
Dr Surekha Rathod |
| Address |
104,Dept of periodontics, Ranjeet deshmukh dental college,440019 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| self |
dept of periodontics |
|
|
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 periodontics, RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE, NAGPUR
Nagpur
MAHARASHTRA |
09011071477
drsurekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet deshmukh dental college and research centre ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
diabeties |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine mouthwash |
20 Stage III periodontitis patients with T2DM receiving NSPT + chlorhexidine mouthwash. |
| Comparator Agent |
Floradent mouthwash. |
20 Stage III periodontitis patients with T2DM receiving NSPT + Floradent mouthwash. |
| Intervention |
scaling |
Stage III periodontitis patients with T2DM receiving NSPT alone for 3 months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have undergone any periodontal therapy in the past 6 months.
2. Patients with systemic diseases other than diabetes.
3. History of any medication including antibiotic treatment within the previous 3
months or regular use of specific drugs known to affect periodontal tissues.
4. Pregnant women and lactating mothers.
|
|
| ExclusionCriteria |
| Details |
Patients who have undergone any periodontal therapy in the past 6 months.
2. Patients with systemic diseases other than diabetes.
3. History of any medication including antibiotic treatment within the previous 3
months or regular use of specific drugs known to affect periodontal tissues.
4. Pregnant women and lactating mothers.
|
|
|
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 |
Plaque Index (PI)
Gingival Index (GI)
Papillary Bleeding Index (PBI)
Probing Pocket Depth (PPD)
Clinical Attachment Level (CAL) |
baseline 1,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/04/2026 |
| 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
|
While
single-herb-based mouthwashes are available on the market, there is a lack of
literature on polyherbal mouthwashes for the treatment of periodontitis in
diabetic patients. So the aim of the study is to evaluate the effect of orange peel and s. cumuni seed
extract containing Mouthwash on
Periodontal Health in Type 2 Diabetes Mellitus Patients.
|