| CTRI Number |
CTRI/2026/03/106029 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Herbal Mouth Gel and Chlorhexidine Gel for Treating Gum Inflammation in Adults Aged 18–40 Years in Shivamogga city. |
|
Scientific Title of Study
|
Evaluation and Comparison of Herbal Mouth Gels with Chlorhexidine Gel Among 18 to 40 Year Adults with Gingivitis in Shivamogga City A Double Blinded Randomized Controlled Trail |
| 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 Seema P |
| Designation |
Post Graduate |
| Affiliation |
Subbaiah Institute of Dental Sciences |
| Address |
Room number 7 Department of Public Health Dentistry Subbaiah Institute of Dental Sciences NH 13 Purle Shivamogga 577222
Shimoga
KARNATAKA
577222
India |
| Phone |
9513668322 |
| Fax |
|
| Email |
seemapatyge8909@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preethi Nagdev |
| Designation |
Reader |
| Affiliation |
Subbaiah Institute of Dental Sciences |
| Address |
Room number 7 Department of public health Dentistry Subbaiah Institute of Dental Sciences NH 13 Purle Shivamogga 577222
Shimoga
KARNATAKA
577222
India |
| Phone |
9964523332 |
| Fax |
|
| Email |
preethinagdev86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema P |
| Designation |
Post Graduate |
| Affiliation |
Subbaiah Institute of Dental Sciences |
| Address |
Room number 7 Department of Public Health Dentistry Subbaiah Institute of Dental Sciences NH 13 Purle Shivamogga 577222
Shimoga
KARNATAKA
577222
India |
| Phone |
9513668322 |
| Fax |
|
| Email |
seemapatyge8909@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry Room no 07 Subbaiah institute of Dental Sciences NH 13 Purle Shivamogga Karnataka 577222 |
|
|
Primary Sponsor
|
| Name |
Subbaiah institute of Dental Sciences |
| Address |
Room number 7 Department of Public Health Dentistry Subbaiah Institute of Dental Sciences NH13 Purle Shivamogga 577222 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Suresh B S |
Subbaiah Institute of Dental Sciences Shivamogga |
Department of Public Health Dentistry Room no 07 Subbaiah Institute of Dental Sciences NH 13 Purle Shivamogga 577222
Shimoga
KARNATAKA |
9229991000
principalsubbaiahdental@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shivamogga |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K051||Chronic gingivitis. Ayurveda Condition: DANTAMULAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Giloy mouth gel, Reference: NA, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Pomegranate mouth gel, Reference: NA, Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | | - | 1% Chlorhexidine mouth gel | Apply 1g of 1% Chlorhexidine gluconate mouth gel onto the gingiva using index finger, gently massaged for 2 minutes, and rinsed immediately. The procedure will be performed twice daily in the morning and at night after brushing for 14 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Residents of Shivamogga
Participants willing to take part
Participants aged 18 TO 40 years
Participants with moderate to severe gingivitis
Participants with presence of atleast 24 natural teeth |
|
| ExclusionCriteria |
| Details |
Participants with systemic diseases or conditions
Participants with long term exposure to antibiotics anti inflammatory drugs and with the history of periodontal therapy in last 4 to 6 weeks
Participants with the habit of smoking tobacco chewing and alcohol consumption
Pregnant and lactating women
Participants undergoing orthodontic treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of moderate to severe Gingivitis using gingival index and plaque index |
baseline, 7days, 14days, 21days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
01/09/2026 |
| 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="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
|
Aim of the study The aim of the study is to evaluate and compare the effectiveness of Giloy gel and Pomegranate gel with chlorhexidine gel among 18-40 year adults with gingivitis in Shivamogga city
Objectives of the study To assess the effectiveness of Giloy gel in the treatment of gingivitis using Gingival index and Plaque index (Harald Loe, 1967) To assess the effectiveness of Pomegranate gel in the treatment of gingivitis using Gingival index and Plaque index (Harald Loe, 1967) To assess the effectiveness of Chlorhexidine gel in the treatment of gingivitis using Gingival index and Plaque index (Harald Loe, 1967) To compare the effectiveness of Giloy gel, Pomegranate gel with Chlorhexidine gel in the treatment of gingivitis using Gingival index and Plaque index (Harald Loe, 1967)
Research Question: Is there any effectiveness of Giloy gel, Pomegranate gel in comparison with Chlorhexidine gel in reducing the gingivitis among 18-40 year adults in Shivamogga city?
Research Hypothesis(H1): There is an effectiveness of Giloy gel, Pomegranate gel in comparison with Chlorhexidine gel in reducing the gingivitis among 18-40 year adults in Shivamogga city.
Null Hypothesis(H0): There is no effectiveness of Giloy gel, Pomegranate gel in comparison with Chlorhexidine gel in reducing the gingivitis among 18-40 year adults in Shivamogga city.
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