| CTRI Number |
CTRI/2025/08/092528 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Pomegranate mouth rinse and Chlorhexidine on plaque accumulation, gingival inflammation and salivary bacterial count. |
|
Scientific Title of Study
|
Efficacy of pomegranate mouth rinse compared to chlorhexidine on plaque accumulation, gingival inflammation and salivary bacterial count -A Randomised 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 |
Anoop S |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College, Thiruvananthapuram |
| Address |
Department of periodontics,
Government Dental College, Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8891264263 |
| Fax |
|
| Email |
anoopperio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anoop S |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College, Thiruvananthapuram |
| Address |
Department of periodontics,
Government Dental College, Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8891264263 |
| Fax |
|
| Email |
anoopperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anoop S |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College, Thiruvananthapuram |
| Address |
Department of periodontics,
Government Dental College, Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8891264263 |
| Fax |
|
| Email |
anoopperio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental college, Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Dr Anoop S |
| Address |
Department of periodontics,
Government Dental College, Thiruvananthapuram |
| 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 Anoop S |
Government Dental College, Thiruvananthapuram |
Department of periodontics,
Government Dental College, Thiruvananthapuram
Thiruvananthapuram
KERALA |
8891264263
anoopperio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, Government Dental college, Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine mouth rinse |
concentration:0.2%
route of administration: topical mouthwash
dosage: 10 ml
frequency: twice daily
duration: 21 days |
| Intervention |
Pomegranate mouth rinse |
concentration: 300mg/ml
route of administarion: topical mouthwash
dosage: 10ml
frequency : twice daily after brushing
duration: 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with a gingival index score ≥1 and a plaque index score ≥1, a minimum of 12 gradable teeth, no requirement for emergency oral prophylaxis, and willing to give written informed consent to participate in the study and comply with the study visits. |
|
| ExclusionCriteria |
| Details |
Individuals with history of steroid or antimicrobial therapy in the last 3 months
Individuals with any medical condition
Smokers
Adults with periodontitis
Allergic to chlorhexidine and pomegranate
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
plaque index (Silness and Loe)
gingival index (Loe and Silness)
salivary bacterial colony forming units |
baseline, 5days, 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| Date of Study Completion (India) |
03/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
To determine the effect of
herbal mouthwash prepared from pomegranate peel compared to chlorhexidine
mouthwash in reducing plaque accumulation, gingival health, and salivary
bacterial count. |