FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093201 [Registered on: 18/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to find out if adding turmeric gel or antibiotic fibres to gum cleaning treatment helps improve gum health 
Scientific Title of Study   Efficacy of subgingivally delivered curcumin gel and tetracycline fibres as an adjunct to scaling and root planing: A clinico-biochemical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karnika Agrawal 
Designation  Junior Resident 1 
Affiliation  Kothiwal Dental College and Research Centre, Moradabad 
Address  Kothiwal dental college and research centre, Haridwar road, Mohra ki milak, Moradabad, Uttar Pradesh 244001

Moradabad
UTTAR PRADESH
244001
India 
Phone  6352004589  
Fax    
Email  karnikagrawal@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Agarwal 
Designation  Professor 
Affiliation  Kothiwal Dental College and Research Centre, Moradabad 
Address  Kothiwal dental college and research centre, Haridwar road, Mohra ki milak, Moradabad, Uttar Pradesh 244001

Moradabad
UTTAR PRADESH
244001
India 
Phone  8192917937  
Fax    
Email  swatimds86@gmail.com  
 
Details of Contact Person
Public Query  
Name  Karnika Agrawal 
Designation  Junior Resident 1 
Affiliation  Kothiwal Dental College and Research Centre, Moradabad 
Address  Kothiwal dental college and research centre, Haridwar road, Mohra ki milak, Moradabad, Uttar Pradesh 244001

Moradabad
UTTAR PRADESH
244001
India 
Phone  6352004589  
Fax    
Email  karnikagrawal@gmail.com  
 
Source of Monetary or Material Support  
Kothiwal Dental College And Research Centre, Haridwar Road, Mohra ki Milak, Moradabad, Uttar Pradesh, 244001 
 
Primary Sponsor  
Name  Karnika Agrawal 
Address  Kothiwal dental college and research centre, Haridwar road, Mohra ki milak, Moradabad, Uttar Pradesh 244001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karnika Agrawal  Kothiwal Dental college and Research Centre  Room no. 3, Department of Periodontology, Kothiwal dental college and research centre, Haridwar road, Mohra ki milak, Moradabad, Uttar Pradesh 244001
Moradabad
UTTAR PRADESH 		 6352004589

karnikagrawal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics and Review Board, Kothiwal dental college and research centre, Moradabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curenext oral gel (curcuma oral gel)   1gm of Curcuma oral gel [from Abbott healthcare Pvt. Ltd. Manufactured by Akums drug & pharmaceuticals limited. Plot No. 47-48, Sector-6A, Sidcul, Haridwar (U.K.)- 249403, India] contains Curcuma longa extract (Rhizome) - 10 mg. Post interventional scaling and root planing the gel is injected into the pocket for reduction of pocket depth. Duration - 45 minutes.  
Comparator Agent  Periodontal Plus AB (tetracycline fibres)  Each vial of Periodontal Plus AB [Manufactured by Advanced Biotech Products (P) Ltd. PL. 111 to 114,SIDCO Pharma Estate, Alathur 603110, Tamil Nadu, India] contains 25mg Collagen impregnated with 2mg Tetracycline HCl. Post interventional scaling and root planing the fibres are placed into the pocket for reduction of pocket depth. Duration- 50 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Both male and female patients of 18-65 years of age, who are willing to give written informed consent.
Patients with chronic periodontitis with presence of at least two periodontal pockets of greater than or equal to 5mm in the contralateral arch.
Systemically healthy individuals.  
 
ExclusionCriteria 
Details  Patients who have taken antibiotics or have undergone periodontal therapy in last 3 months. Medically compromised patients, mentally disabled and physically handicapped patients.
Pregnant women and lactating mother.
Patients allergic to tetracycline or curcumin gel.
Patients having deleterious habits. 
 
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 Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in CAL and PPD   CAL- 0, 15 days, 3 months
PPD- 0, 15 days, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
PI, mSBI, Interleukin-1 beta  PI- 0, 15 days, 3 months
mSBI- 0, 15 days, 3 months
Interleukin-1 beta- 0, 3 months 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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 4 
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="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [karnikagrawal@gmail.com].

  6. For how long will this data be available start date provided 12-08-2025 and end date provided 12-08-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study outlines the effectiveness of subgingivally delivered curcumin gel and tetracycline fibres as adjuncts to scaling and root planing (SRP) in treating chronic periodontitis (CP). This randomized controlled trial will include 54 systemically healthy patients (18-65 year) suffering from CP with pocket depths of at least 5mm. The study will divide participants into two groups- one receiving SRP followed by tetracycline fibres (control group) and the other receiving SRP followed by curcumin gel (test group). The primary objectives are to compare the reduction in Clinical Attachment Level (CAL) and Probing Pocket Depth (PPD). Secondary objectives include assessing the Plaque index (PI), Modified Sulcular Bleeding Index (mSBI) and Interleukin-1 beta (IL-1 beta) biomarker levels. The study aims to determine if curcumin gel with SRP offers an added benefit in reducing pocket depth and CAL. The assessment of Interleukin-1 beta biomarker levels a pro-inflammatory cytokine elevated in periodontitis and contributing to attachment loss will provide biochemical insights into the anti-inflammatory efficacy of these adjunctive therapies. 
Close