| CTRI Number |
CTRI/2025/09/095469 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing pomegranate mouthwash with chlorhexidine in plaque control and gum health |
|
Scientific Title of Study
|
Comparing the efficacy of mouthwash enriched with pomegranate extract versus chlorhexidine mouthwash in the control of plaque and gingivits |
| 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 Manika Rawat |
| Designation |
Post graduate student |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre |
| Address |
Room Number 809
Department of Public Health Dentistry
Teerthanker Mahaveer Dental College and Research Centre, Moradabad, Uttar Pradesh, India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9999613125 |
| Fax |
|
| Email |
rawatmanika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Tangade |
| Designation |
Professor, head of department and guide |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre |
| Address |
Department of Public Health Dentistry
Teerthanker Mahaveer Dental College and Research Centre, Moradabad, Uttar Pradesh, India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9997466339 |
| Fax |
|
| Email |
drpradeeptangade.dental@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Tangade |
| Designation |
Professor, head of department and guide |
| Affiliation |
Teerthanker Mahaveer Dental College and Research Centre |
| Address |
Department of Public Health Dentistry
Teerthanker Mahaveer Dental College and Research Centre, Moradabad, Uttar Pradesh, India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9997466339 |
| Fax |
|
| Email |
drpradeeptangade.dental@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Teerthaker Mahaveer Dental College and Research Centre, Moradabad,Uttar Pradesh 244001, India |
|
|
Primary Sponsor
|
| Name |
Dr Manika Rawat |
| Address |
Room Number 809
Department of public health dentistry
Teerthanker Mahaveer Dental College and Research Centre, Moradabad, Uttar Pradesh 244001,India |
| 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 Manika Rawat |
Teerthanker Mahaveer Dental College and Research Centre |
Room Number 809,Department of Public Health Dentistry,
Teerthanker Mahaveer Dental College and Research Centre, Moradabad, Uttar Pradesh 244001,India
Moradabad
UTTAR PRADESH |
9999613125
rawatmanika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Teerthanker Mahaveer Dental College and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
KO5.10. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine mouthwash to be used for a duration of 21 days |
Commercially available 0.2% chlorhexidine mouthwash
The trial will be for a duration of 21 days where the
participants will be instructed to rinse with 10 ml of solution twice daily for 30 s at the interval of 12 hours |
| Intervention |
Pomegranate extract mouthwash to be used for a duration of 21 days |
0.05% pomegranate peel extract mouthwash
The trial will be for a duration of 21 days where the participants will be instructed to rinse with 10 ml of solution twice daily for 30 s at the interval of 12 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Systematically healthy voluntary participants
Participants with mild to moderate gingivitis
With atleast 20 natural teeth present in the mouth
Participants who are willing to comply with appointment schedule
|
|
| ExclusionCriteria |
| Details |
Participants with any systematic disease
Undergoing orthodontic treatment
Pregnant and nursing females
With positive history of antibiotic, corticosteroid or periodontal therapy in past one month
Using antimicrobial mouthwashes
Smokers
Who refuse to participate in the study |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival health will be assessed using Loe and Silness gingival index and plaque scores which will be assessed using Turesky-Gilmore modification of Quingley hein plaque index |
Data will be recorded at the baseline, 14 days and 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse or unintended effects of mouthwash will be taken as secondary outcome |
14 days and 21 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
14/10/2025 |
| 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="0"
Days="21" |
|
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 - NO
|
|
Brief Summary
|
This study is a randomized double blinded clinical trial to compare the efficacy of a pomegranate peel extract mouthwash with chlorhexidine in managing plaque and gingivitis among 20 patients aged between 18 to 40 years with mild to moderate gingivitis. Participants will be assigned to either the pomegranate group or the chlorhexidine group and will be instructed to rinse twice daily for 21 days. Clinical parameters including Plaque Index and Gingival Index will be assessed at baseline 14 days and 21 days. Findings from this study will help determine whether pomegranate which is a natural agent with antimicrobial and anti-inflammatory properties can serve as a safe and effective alternative to chlorhexidine which despite its efficacy is associated with side effects such as tooth staining and altered taste. |