| CTRI Number |
CTRI/2026/04/107841 [Registered on: 08/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of a natural bee product (propolis) mouth rinse and chlorhexidine mouth rinse for improving gum health and lowering bacteria after full-mouth deep cleaning in people with moderate gum disease. |
|
Scientific Title of Study
|
Comparative evaluation of clinical outcomes and microbial load after one-stage full mouth disinfection with 20% propolis hydroalcoholic rinse and 0.2% chlorhexidine rinse in stage II grade B periodontitis patients: a single-blind 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 |
sanskruti kulkarni |
| Designation |
post graduate student |
| Affiliation |
MGVS KBH dental college and hospital,panchvati,nashik |
| Address |
301, Department of Periodontology, KBH Dental College and Hospital, Panchvati, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7776992006 |
| Fax |
|
| Email |
sanskul40@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Triveni kale |
| Designation |
professor and PG guide |
| Affiliation |
MGVS KBH dental college and hospital,panchvati,nashik |
| Address |
301, Department of Periodontology, KBH Dental College and Hospital, Panchvati, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
8552011711 |
| Fax |
|
| Email |
trivenikale@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
sanskruti kulkarni |
| Designation |
post graduate student |
| Affiliation |
MGVS KBH dental college and hospital,panchvati,nashik |
| Address |
301, Department of Periodontology, KBH Dental College and Hospital, Panchvati, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7776992006 |
| Fax |
|
| Email |
sanskul40@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
sanskruti kulkarni |
| Address |
Gayatri niwas,soubhagya nagar,latur 413512 |
| 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 |
| sanskruti kulkarni |
MGVS KBH dental college and hospital |
301, Department of Periodontology, MGVs KBH dental college and Hospital, Nashik
Nashik
MAHARASHTRA |
7776992006
sanskul40@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KBH Dental college institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Generalised periodontitis stage II grade B |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
One-stage full-mouth disinfection with 0.2 percent chlorhexidine rinse |
Subjects will receive one-stage full-mouth disinfection using 0.2% chlorhexidine rinse in a single clinical session. After full-mouth scaling and root planing, patients will rinse with 0.2% chlorhexidine for 2 minutes, brush the dorsum of the tongue for 1 minute, and undergo subgingival irrigation with 0.2% chlorhexidine rinse (3 times within 10 minutes). Participants will then use 2 ml of the rinse twice daily for 2 weeks (14 days). |
| Intervention |
One-stage full-mouth disinfection with 20 percent propolis hydroalcoholic rinse |
Subjects will receive one-stage full-mouth disinfection using 20% propolis hydroalcoholic rinse in a single clinical session. After full-mouth scaling and root planing, patients will rinse with 20% propolis hydroalcoholic rinse for 2 minutes, brush the dorsum of the tongue for 1 minute, and undergo subgingival irrigation with 20% propolis rinse (3 times within 10 minutes). Participants will then use 2 ml of the rinse twice daily for 2 weeks (14 days). |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Participants maintaining good oral hygiene after completion of scaling and root planing.
Patients diagnosed with stage II grade B periodontitis three or more nonadjacent teeth with pockets more than or equal to 5 mm
|
|
| ExclusionCriteria |
| Details |
Patients with chronic diseases such as diabetes mellitus, arthritis, thyroid disorder, etc.
Patients who are smokers or using any other tobacco products.
Patients who had undergone subgingival instrumentation within 12 months before the baseline examination.
Patients with compromised medical conditions which required prophylactic antibiotic coverage
Patients who had used antimicrobial agents 4 months before the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in clinical periodontal parameters, including Gingival Index (GI), Plaque Index (PI), Modified Sulcus Bleeding Index (MSBI), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL), following one-stage full mouth disinfection using 20% propolis hydroalcoholic rinse and 0.2% chlorhexidine rinse in Stage II Grade B periodontitis patients. |
Change in clinical periodontal parameters, including Gingival Index (GI), Plaque Index (PI), Modified Sulcus Bleeding Index (MSBI), Probing Pocket Depth (PPD), and Clinical Attachment Level (CAL), following one-stage full mouth disinfection using 20% propolis hydroalcoholic rinse and 0.2% chlorhexidine rinse in Stage II Grade B periodontitis patients at 24 hours and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in microbial load assessed by colony forming units (CFUs) following one-stage full mouth disinfection using 20% propolis hydroalcoholic rinse and 0.2% chlorhexidine rinse in Stage II Grade B periodontitis patients. |
baseline, 24 hours, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/04/2026 |
| 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="1"
Months="5"
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 randomized single-blind clinical trial aims to compare the effectiveness of 20 percent propolis hydroalcoholic rinse with the gold-standard 0.2 percent chlorhexidine rinse when used as part of a one-stage full-mouth disinfection (OSFMD) protocol in Stage II Grade B periodontitis patients. A total of 40 patients will be randomly assigned into two equal groups (20 each): All participants will undergo full-mouth scaling and root planing within 24 hours, followed by mouth rinsing, tongue brushing, and subgingival irrigation with their respective rinses. They will continue using the assigned rinse (2 ml twice daily) for 2 weeks. The study evaluates clinical outcomes—gingival index, plaque index, modified sulcus bleeding index, probing pocket depth, and clinical attachment level—along with microbial load (colony forming units) at three intervals: -
Baseline -
24 hours -
12 weeks The primary objective is to determine whether propolis performs comparably or better than chlorhexidine in improving periodontal clinical parameters. The secondary objective is to assess differences in microbial load reduction between the two groups. The study follows simple random sampling, SNOSE allocation concealment, and involves an examiner-blinded assessment. Statistical analysis will be performed using SPSS with significance set at p less than 0.05. Overall, the study aims to explore whether propolis, a natural agent with antibacterial and anti-inflammatory properties and fewer side effects, can serve as an effective alternative to chlorhexidine in periodontal therapy. |