| CTRI Number |
CTRI/2025/05/086082 [Registered on: 01/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of herbal mouthwash on gums of patients with gum disease. |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy of Herbal mouthwash containing Grapefruit seed extract and Chlorhexidine Mouthwash on Chronic Gingivitis: A Randomized Controlled Clinical 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 Saurabh Prithyani |
| Designation |
Reader |
| Affiliation |
Terna Dental College |
| Address |
101, First floor, Department of Periodontology, Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
07208020305 |
| Fax |
|
| Email |
saurabh.prithyani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Dipika Mitra |
| Designation |
Professor and Head of Department |
| Affiliation |
Terna Dental College |
| Address |
101, first floor, Department of Periodontology, Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706
Railway station, Sector 22,Nerul,Navi Mumbai Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
07420830981 |
| Fax |
|
| Email |
drdipikamitra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanika Girish Patil |
| Designation |
Post graduate student |
| Affiliation |
Terna Dental College |
| Address |
101, First floor, Department of Periodontology, Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
07420830981 |
| Fax |
|
| Email |
drsanika99@gmail.com |
|
|
Source of Monetary or Material Support
|
| 101, First floor, Department of Periodontology, Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706 |
|
|
Primary Sponsor
|
| Name |
TPCTs Terna Dental College |
| Address |
Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706 |
| 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 Sanika Patil |
Terna Dental College |
101, First floor, Department of Periodontology, Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706
Thane
MAHARASHTRA |
07420830981
drsanika99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Systemically healthy patients with chronic gingivitis. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine mouthwash |
All patients with chronic gingivitis will be treated with scaling and root planing. Baseline evaluation will be done for plaque index, gingival index, oral hygiene index simplified. Patients will be given chlorhexidine mouthwash to use for 14 days. Patient will be recalled after 7 days and 14 days for follow-up. |
| Intervention |
Oral mouthwash containing grapefruit seed extract |
All patients with chronic gingivitis will be treated with scaling and root planing. Baseline evaluation will be done for plaque index, gingival index, oral hygiene index simplified. Patient will be given mouthwash to use for 14 days. Patient will be recalled after 7 days and 14 days for follow-up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 and 65 years of age suffering from chronic gingivitis were
considered for inclusion in this study. |
|
| ExclusionCriteria |
| Details |
1. Advanced periodontal disease or severely malaligned teeth. 2. Patients suffering from any known systemic diseases.3.Smokers and alcoholic patients.4. Pregnancy or lactatingfemale patients.5.Patients who have received surgical or nonsurgical periodontal therapy in last 3 months prior to the baseline visit.6.•Patients who have allergic to propolis products. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of a Herbal mouthwash containing
Grapefruit seed extract and Chlorhexidine mouthwash in treating Gingivitis. |
At Baseline
After 7 days
After 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
30/05/2025 |
| 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="14" |
|
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
|
This is a Randomized controlled clinical trial to compare the efficacy of grapefruit seed extract mouthwash and chlorhexidine mouthwash on chronic gingivitis.
STUDY DESIGN Group A consists of 40 subjects with chronic gingivitis receiving grapefruit seed extract mouthwash. Group B consists of 40 subjects with chronic gingivitis receiving chlorhexidine mouthwash. Clinical parameters like Oral hygiene index simplified, Plaque index and Gingival index will be evaluated at Baseline, after 7 days and after 14 days.
Statistical Package for Social Science(SPSS)version 21 for Windows (Armonk,NY:IBM corp) will be used for data analaysis. |