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CTRI Number  CTRI/2026/02/103400 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Two Healing Gels for Gum Disease Melatonin vs. Pain Relief Gel 
Scientific Title of Study   COMPARATIVE EVALUATION OF 5% MELATONIN GEL VERSUS 5% PIROXICAM GEL IN THE TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS A SPLIT-MOUTH DOUBLE BLIND RANDOMIZED CONTROL CLINICAL 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  Shaik Sameera Sulthana 
Designation  Post graduate student Department of periodontics 
Affiliation  Sri Hasanamba dental college and hospital  
Address  Room no 5 Department of Periodontics Sri Hasanamba dental college and Hospital vidyanagar Hassan
Room no 5 Department of Periodontics Sri Hasanamba Dental College and Hospital Vidyanagar Hassan
Hassan
KARNATAKA
573201
India 
Phone  6304261026  
Fax    
Email  ssameerasulthana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sowmya S 
Designation  Reader 
Affiliation  Sri Hasanamba dental college and hospital  
Address  Room no 5 Department of Periodontics Sri Hasanamba Dental College and Hospital Vidyanagar Hassan
Room no 5 Department of Periodontics Sri Hasanamba Dental College and Hospital Vidyanagar Hassan
Hassan
KARNATAKA
573201
India 
Phone  6362791311  
Fax    
Email  sowmyasadanand@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sowmya S 
Designation  Reader 
Affiliation  Sri Hasanamba dental college and hospital  
Address  Room no 5 Department of Periodontics Sri Hasanamba Dental College and Hospital Vidyanagar Hassan
Room no 5 Department of Periodontics Sri Hasanamba Dental College and Hospital Vidyanagar Hassan
Hassan
KARNATAKA
573201
India 
Phone  6362791311  
Fax    
Email  sowmyasadanand@yahoo.co.in  
 
Source of Monetary or Material Support  
Sri Hasanamba dental college and hospital vidyanagar Hassan Karnataka 573201 
 
Primary Sponsor  
Name  Sri Hasanamba dental college and hospital vidyanagar Hassan Karnataka 573201 
Address  Sri Hasanamba dental college and hospital vidyanagar Hassan Karnataka 573201 
Type of Sponsor  Research institution and hospital 
 
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 
DrShaik Sameera Sulthana  sri Hasanamba dental college and Hospital  Room no 5 Department of periodontics Sri Hasanamba Dental college and Hospital Vidyanagar Hassan 573201 Karnataka
Hassan
KARNATAKA 		 6304261026

ssameerasulthana@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Chronic Generalized Periodontitis  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MELATONIN GEL   Melatonin is a hormone that is synthesized and secreted by the pineal gland. It has anti-inflammmatory and immunomodulatory roles. Melatonin can regulate the synthesis of type 1 collagen and expression of other bone-related proteins, like bone sialoprotein (BSP), alkaline phosphatase. 
Comparator Agent  piroxicam gel  Piroxicam is a COX inhibitor which has anti-inflammatory, antipyretic and analgesic effect. The main mechanism of action of this drug is inhibition of enzyme cyclooxygenase resulting in reduced prostaglandin synthesis. The prostaglandin production inhibitors like non-steroidal anti-inflammatory drugs (NSAIDS), can reduce gingivitis and alveolar bone resorption 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects with age group of 25–65 years.
2. Both the genders will be included
3. Subjects with radiographic evidence of intra bony defects with probing pocket depth of greater 5mm and clinical attachment level greater than 4mm
4. Subjects with at least 20 teeth present with one pair of bilateral or contralateral intrabony defects in either maxillary or mandibular arch
 
 
ExclusionCriteria 
Details  1.Subjects who received any antibiotics therapy or any periodontal treatments in the past six months
2.Subjects with any systemic diseases
3.Pregnant women or lactating mothers
4.Subjects who are smokers and alcoholics
 
 
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 and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction of clinical signs, plaque index, modified sulcus bleeding index, pocket probing depth and gain in clinical attachment level.  0,3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Bone level assessment  0 and 6 months 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   05/03/2026 
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
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Melatonin gel has anti- anti-inflammatory and immunomodulatory roles. It can regulate the synthesis of type 1 collagen and expression of other bone-related proteins, like bone sialoprotein (BSP), alkaline phosphatase.
Piroxicam gel is a COX inhibitor which has anti-inflammatory, antipyretic and analgesic effect. The main mechanism of action of this drug is inhibition of enzyme cyclooxygenase resulting in reduced prostaglandin synthesis.
The prostaglandin production inhibitors like non-steroidal anti-inflammatory drugs (NSAIDS), can reduce gingivitis and alveolar bone resorption.
This study will compare the clinical and radiographic effectiveness of 5% melatonin gel and 5% piroxicam gel in the treatment of intrabony defects in patients with chronic periodontitis using a split-mouth, double-blind, randomized controlled clinical trial design. The gels will be locally delivered following periodontal therapy, and their outcomes will be evaluated based on changes in probing depth, clinical attachment level, and radiographic bone fill over a defined follow-up period. The study will aim to determine which agent provides superior periodontal regeneration and anti-inflammatory benefits.
 
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