| CTRI Number |
CTRI/2025/07/090187 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of the efficacy of herbal mouthwash with
chlorhexidine mouthwash, as an adjunct to scaling and polishing in
the treatment of subjects with Mild to Moderate Gingivitis - A
Randomised Clinical Trial. |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of herbal mouthwash with chlorhexidine mouthwash, as an adjunct to scaling and polishing in the treatment of subjects with mild to moderate gingivitis- a randomized clinical 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 SANGEETA MUGLIKAR |
| Designation |
Head Of Department |
| Affiliation |
Intern |
| Address |
sector 4, belpada road, kharghar, navi mumbai, maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9742501587 |
| Fax |
|
| Email |
drmuglikar2006@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VAIBHAV KUMAR |
| Designation |
Incharge, Dept of Public Health Dentistry |
| Affiliation |
Dr GD Pol Foundation YMT Dental College and Hospital, Navi Mumbai |
| Address |
Sector 4, Belpada road, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9372235480 |
| Fax |
|
| Email |
drvaibhav1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANGEETA MUGLIKAR |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
Dr GD Pol Foundation YMT Dental College and Hospital, Navi Mumbai |
| Address |
Sector 4, Belpada Road, Kharghar, Navi Mumbai, Maharashtra 410210
Mumbai (Suburban)
MAHARASHTRA
410210
India |
| Phone |
9372235480 |
| Fax |
|
| Email |
drmuglikar2006@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| DR G.D.POL FOUNDATION YERALA DENTAL COLLEGE - YMT DENTAL COLLEGE , 18, BELPADA RD, SECTOR 4 , KHARGHAR , NAVI MUMBAI , MAHARASHTRA 410210 |
|
|
Primary Sponsor
|
| Name |
Yerala Dental College |
| Address |
Yerala Dental College, 18, Belpada Road, Sector 4, Kharghar , Navi Mumbai, Maharashtra 410210 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sangeeta Muglikar |
Dr GD Pol Foundation YMT Dental College and Hospital |
Department no 3A, Department of periodontics, YMT Dental College and Hospital, Sector 4, Institutional Area, Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA |
9742501587
drmuglikar2006@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Y.MT. Dental College and Hospital, Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine mouthwash |
0.2% chlorhexidine mouthwash is used as comparatoor agent to treat mild to moderate gingivitis
Duration: 10 ml 2 times for 21days |
| Intervention |
Herbal mouthwash |
CONTENTS :Bayberry Bark - Psidium guajava, Curcuma longa Mentha piperita, Myristica fragrans - Cinnamomum verum,
Trigonella foenum - Syzygium aromaticum, Commiphora wightii -
Lavandula angustifolia, Phyllanthus emblica - Glycyrrhiza glabra,
Triticum aestivum - Salvadora persica, Spilanthes acmella,
Glucoside, Stevia powder, Citric Acid, Peppermint oil, Rock Salt,
Fennel Seed Oil, Sorbitol, Sodium Bicarbonate
duration : 10ml 2 times for 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1)subjects with age group between 18 to 30 years
2)subjects with minimum 20 teeth present
3)subjects with mild to moderate gingivitis
4)systemically healthy and cooperative subjects
5)subjects willing to take part in study |
|
| ExclusionCriteria |
| Details |
1) presence of fixed or partial dentures or removable dentures
2) subjects with history of antibiotic and anti inflammatory drugs within 1 month
3) pregnant women , women on oral contraceptive medication and lactating mothers
4) subjects who are smokers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Gingival index
Plaque index
OHI-s |
baseline and 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
0.0-1.2 good oral hygiene
1.3-3.0 fair
3.1-6.0 poor |
10days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="2"
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
|
Gingivitis is caused by plaque accumulation on tooth surfaces. The bacteria produce toxic antigens that lead to an inflammatory reaction in the gingival tissue. Gingivitis can eventually evolve to periodontitis with loss of supporting bone and periodontal attachment around the teeth. Chlorhexidine which is a broad-spectrum antimicrobial agent is considered as the gold standard for chemical plaque control. But continuous use of chlorhexidine has side effects such as increase in calculus formation, alteration in taste, oral mucosal erosion . Gingivitis is caused by plaque accumulation on tooth surfaces. The bacteria produce toxic antigens that lead to an inflammatory reaction in the gingival tissue. Gingivitis can eventually evolve to periodontitis with loss of supporting bone and periodontal attachment around the teeth. Chlorhexidine which is a broad-spectrum antimicrobial agent is considered as the gold standard for chemical plaque control. Herbal medicine have long been used as mouthwash and this practice is still relevant in many regions. The present study aims to evaluate and compare the efficacy of herbal mouthwash pre and post after use. It also aims to evaluate the adverse drug reaction caused on using chlorhexidine mouthwash. |