| CTRI Number |
CTRI/2025/07/092076 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Toothpaste] |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Herbal Propolis and Regular Toothpastes Along with Cleaning in Patients with Gum Inflammation |
|
Scientific Title of Study
|
Comparative evaluation of Propolis containing dentifrice and standard dentifrice as an adjunct to oral prophylaxis in plaque induced gingivitis patients A Randomized 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 |
Dr Shruti Anna Karande |
| Designation |
1st Year MDS student |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
402, 4th floor Department of Periodontology, Bharati Vidyapeeth Dental College and Hospital,sector 7 Belpada, Belapur Navi Mumbai.
Bharati Vidyapeeth Dental College and Hospital,sector 7 Belpada, Belapur Navi Mumbai.
Thane
MAHARASHTRA
410210
India |
| Phone |
7057467977 |
| Fax |
|
| Email |
drshrutikarande@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh V Joshi |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
402, Department of Periodontology, Bharati Vidyapeeth Dental College and Hospital,sector 7 Belpada, Belapur Navi Mumbai.
Bharati Vidyapeeth Dental College and Hospital,sector 7 Belpada, Belapur Navi Mumbai.
Thane
MAHARASHTRA
410210
India |
| Phone |
98224 04515 |
| Fax |
|
| Email |
nilesh.joshi@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Anna Karande |
| Designation |
MDS Periodontology |
| Affiliation |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
| Address |
402, 4th floor, department of Periodontology Bharati Vidyapeeth Dental College and Hospital,sector 7 Belpada, Belapur Navi Mumbai.
Bharati Vidyapeeth Dental College and Hospital,sector 7 Belpada, Belapur Navi Mumbai.
Thane
MAHARASHTRA
410210
India |
| Phone |
7057467977 |
| Fax |
|
| Email |
drshrutikarande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Shruti Anna Karande
Bharati Vidyapeeth Dental College and Hospital, Kharghar, Navi Mumbai, Maharashtra, India 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Anna Karande |
| Address |
Bharati Vidyapeeth Dental College and Hospital,Navi Mumbai, Maharashtra India 410210 |
| 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 Shruti Anna Karande |
Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai |
402, 4th floor, Department of Periodontology, Bharati Vidyapeeth Dental College and Hospital, sector 7 Belpada, CBD Belapur, Nvi Mumbai
Thane
MAHARASHTRA |
07057467977
drshrutikarande@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee for biomedical and health research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Commonly used fluoridated toothpaste |
compare propolis containing and other commonly used dentifrice |
| Intervention |
Propolis containing dentifrice |
Toothpaste that has propolis in it. The total duration of 3 month which has 1 month and 3 month follow up from baseline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients above the age of 18 years of either sex.
2.Patients with at least 20 teeth present.
3.Patients who are systemically healthy.
4.Patients with plaque induced gingivitis.
5.Patients characterized by a gingival index score of at least 1.
|
|
| ExclusionCriteria |
| Details |
1. Patients with any systemic diseases, which may affect the gingival status.
2. Patients who had used antibiotics, anti-inflammatory agents in the past 3 months.
3. Patients with any form periodontitis (clinical attachment loss).
4. Pregnant or lactating women.
5. Tobacco users in any form.
6. Patients with known allergy to honey and honey products.
7. Patients with any orthodontic appliances or prosthesis that would interfere
with the evaluation.
8. Subjects using mouthwash or any other chemical anti-plaque agent as
adjunctive oral hygiene methods.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the clinical and microbiological analysis of Probing depth, bleeding on probing and plaque index |
From Baseline to 1 month and then 3 month follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
18/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
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 is a randomized controlled trial for assessing and comparing the two different dentifrices one is Propolis containing and other is commonly used among patients. And do the clinical and microbiological analysis. This study is done for thesis of postgraduation. The aim of the study is to compare propolis containing toothpaste with common toothpaste. This will be done in patient with plaque induced gingivitis. It will be done after scaling and root planing |