| CTRI Number |
CTRI/2025/10/096287 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of the Efficacy of Curcumin Gel and Tetracycline Gel as an Adjunct to Scaling and Root Planing by Azurocidin Level in Gingival Crevicular Fluid |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Compare the Efficacy of Curcumin Gel and Tetracycline Gel as an Adjunct to Scaling and Root Planing by Azurocidin Level in Gingival Crevicular Fluid |
| 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 DIWAKAR K |
| Designation |
POST GRADUATE |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Room no-422 Department of Periodontology Faculty of dental sciences Uttar Pradesh University of Medical Sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
09008292625 |
| Fax |
|
| Email |
diwakgf84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bipin Kumar Yadav |
| Designation |
PROFESSOR |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, |
| Address |
Department of Periodontology Faculty of dental sciences Uttar Pradesh University of Medical Sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8449619482 |
| Fax |
|
| Email |
drbipinyadav@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bipin Kumar Yadav |
| Designation |
PROFESSOR |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, |
| Address |
Department of Periodontology Faculty of dental sciences Uttar Pradesh University of Medical Sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8449619482 |
| Fax |
|
| Email |
drbipinyadav@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology, Faculty of dental sciences, Uttar Pradesh University of dental
sciences, Saifai, Etawah, Uttar Pradesh, India. pincode - 206130 |
|
|
Primary Sponsor
|
| Name |
Dr DIWAKAR K |
| Address |
A-312, Swami Vivekananda hostel, new campus Uttar Pradesh University of Medical Sciences, Saifai, Etawah -206130 |
| 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 DIWAKAR K |
Uttar Pradesh University of Medical Sciences |
Room no-422, Department of Periodontology, Faculty of Dental Sciences, Uttar Pradesh University of Medical Sciences, Saifai, Etawah Uttar Pradesh, India. Pin-206130.
Etawah
UTTAR PRADESH |
09008292625
diwakgf84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Uttar Pradesh University of Medical Sciences |
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 |
| Intervention |
Curcumin gel |
Scaling and Root Planing and Curcumin gel as locally delivered drug.
Dose-2% Curcumin in 100 ml.
frequency-once in 4 weeks
Route of administration -Local application in periodontal pocket.
Duration-4 weeks
|
| Comparator Agent |
Scaling and Root Planing |
Scaling and Root Planing with no drug placement |
| Intervention |
Tetracycline gel |
Scaling and Root Planing and Tetracycline gel as locally delivered drug.
Dose-0.5% Tetracycline Hydrochloride in 100 ml.
Frequency-once in 4 weeks
Route of administration -Local application in periodontal pocket.
Duration-4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient with bilateral nearly symmetrical chronic periodontitis were selected for this study with Probing pocket depth 5 mm- 7 mm and were Systemically healthy.
|
|
| ExclusionCriteria |
| Details |
Pregnant women or lactating mother, Smokers, Alcoholics, Patients who underwent periodontal therapy, Used antibiotics/ analgesics/ anti-inflammatory drugs in the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL) as clinical parameters and Azurocidin as biochemical parameter. |
Probing Pocket Depth and Clinical Attachment Level will be assessed on baseline and 4 weeks. and GCF samples will be collected for Azurocidin analysis on baseline 2 weeks and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
plaque index (PI) & gingival
index (GI) |
PI & GI will be assessed on baseline 2 weeks & 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
14/11/2025 |
| 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="6"
Days="0" |
|
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
|
Tetracycline is a bacteriostatic antibiotic and first us as locally delivered drug to treat periodontitis. Curcumin is an anti-inflammatory compound derived from Curcumin longa. The efficacy of Tetracycline and curcumin as an adjunct to conventional non-surgical therapy will be determined in the present study. study aims to evaluate and compare the efficacy of curcumin gel and tetracycline gel by clinical parameters and azurocidin level in GCF. A split mouth, single blind, randomized controlled clinical trial will be conducted. Seventy- five patients diagnosed with moderate to severe chronic periodontitis with bilateral nearly symmetrical sites having PPD 5mm to 7 mm will be included in the study. 3 sites in each patient will be randomly selected and named as Group I,II and III. Group I, SRP only, Group II, SRP with curcumin gel and Group III, SRP with tetracycline gel. The clinical parameters PI, GI will be measured at baseline, 15th day 30th day with collection of GCF samples for azurocidin level evaluation, whereas PPD and CAL will be recorded at baseline,15th day and 30th day. This study expects better reduction of inflammation on sites treated with curcumin compare tetracycline when us as an adjunct to SRP in chronic periodontitis patients. |