| CTRI Number |
CTRI/2026/02/102844 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different cleaning protocol on gums and bone health and C reactive protein levels in severe periodontitis cases |
|
Scientific Title of Study
|
Comparative study of C-reactive protein levels and periodontal outcomes in chronic periodontitis patient undergoing Non-Surgical Periodontal Therapy with subgingival irrigation of propolis extract versus chlorhexidine digluconate - 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 Jha Sonuanand |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
112 Department of Periodontology and Implantology Government Dental College and Hospital Navagam Ghed Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9867467103 |
| Fax |
|
| Email |
jhasonu1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Patel |
| Designation |
Dean and Head of Department |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
112 Department of Periodontology and Implantology Government Dental College and Hospital Navagam Ghed Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayana Patel |
| Designation |
Dean and Head of Department |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
112 Department of Periodontology and Implantology Government Dental College and Hospital Navagam Ghed Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital Jamnagar |
|
|
Primary Sponsor
|
| Name |
Dr Jha Sonuanand |
| Address |
112 Government Dental College and Hospital Jamnagar Navagam Ghed Jamnagar Gujarat |
| 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 Jha Sonuanand |
Government Dental College and Hospital, Jamnagar |
112 Department of Periodontology and Implantology, Navagam Ghed Jamnagar
Jamnagar
GUJARAT |
09867467103
jhasonu1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, M.P. SHAH MEDICAL COLLEGE AND GURU GOBINDSINGH HOSPITAL, JAMNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine irrigation |
After full mouth ultrasonic scaling chlorhexidine subgingival irrigation will be done and the patient will be recalled for follow up |
| Intervention |
Propolis extract Irrigation |
After full mouth ultrasonic scaling propolis extract subgingival irrigation will be done and the patient will be recalled for follow up |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Chronic Periodontitis
Probing pocket Depth 3-6mm
No history of periodontal treatment in last 6 months
No systemic disease affecting periodontal health |
|
| ExclusionCriteria |
| Details |
Systemic disease like diabetes, cardiovascular disease
pregnant or lactating females
current tobacco chewer or smoker
allergy to propolis or chlorhexidine
antimicrobial therapy during or before treatment
pocket depth greater than 6 mm |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in C reactive protein levels measured at baseline and 1 month |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| periodontal parameters measured at baseline 1 month and 3 months |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/02/2026 |
| 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="6"
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 controlled trial aims to compare the effects of subging`val irigation wit propolis extract and chlorhexidine dia luconate as adf undts to non-suroi cal perfodo tal therapy (NSPT) in chronic periodontitis patients. Sidy participants will be randomly allocated into two groups: Group A (10% propols aatract) and Group B (02% chlorhexi digluconate). C-reactive protein (CRP) levels and periodontal paramcters - probing depth, dinical attachment level, gingival index, and plague index- w I be eralated at baserne 1 month, and 3 months The study expects both interventions to reduce inlammation and improve dinical outcomes, with propols potentie lly oflering comp-rable or supei efficacy to chlorhexidine |