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CTRI Number  CTRI/2023/01/048820 [Registered on: 09/01/2023] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Efficacy of melatonin with ibuprofen chronotherapy after periodontal surgery  
Scientific Title of Study   A randomized controlled, double blind cross over trial to compare the efficacy of melatonin with ibuprofen chronotherapy to ibuprofen chronotherapy alone in reducing the pain perception after periodontal surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Supriya Mishra 
Designation  Consultant  
Affiliation  Government dental College and hospital raipur  
Address  Department of periodontology Government dental College and hospital, rajbandha maidan, near marhi mata mandir raipur

Raipur
CHHATTISGARH
490006
India 
Phone  08223859339  
Fax    
Email  dr.supriya4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Supriya Mishra 
Designation  Consultant  
Affiliation  Government dental College and hospital raipur  
Address  Department of periodontology Government dental College and hospital, rajbandha maidan, near marhi mata mandir raipur

Raipur
CHHATTISGARH
490006
India 
Phone  08223859339  
Fax    
Email  dr.supriya4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Supriya Mishra 
Designation  Consultant  
Affiliation  Government dental College and hospital raipur  
Address  Department of periodontology Government dental College and hospital, rajbandha maidan, near marhi mata mandir raipur

Raipur
CHHATTISGARH
490006
India 
Phone  08223859339  
Fax    
Email  dr.supriya4@gmail.com  
 
Source of Monetary or Material Support  
Bhilai dental care  
 
Primary Sponsor  
Name  Supriya Mishra  
Address  Bhilai dental care Sector 4 main market Bhilai chhattisgarh  
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 
Supriya Mishra   Bhilai dental care   Bhilai dental care Sector 4 main market Bhilai
Durg
CHHATTISGARH 		 8223859339

dr.supriya4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MCDRC ERB  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 
Comparator Agent  Ibuprofen chronotherapy   After periodontal surgery patients will be given ibuprofen 400mg twice daily for 3 days at 8am and 2 pm. Pain perception will be checked 24 hrs, 48 hrs and 72 hrs post surgery using 10 point VAS scale.  
Comparator Agent  Ibuprofen standard therapy   After periodontal surgery patients will be given ibuprofen 400 MG thrice daily for 3 days at 8am, 2pm and 8pm. Pain perception will be checked using 10 point VAS scale at 24hrs, 48 hrs and 72 hrs post surgery. 
Intervention  Melatonin plus ibuprofen chronotherapy   After periodontal surgery patients will be given ibuprofen 400mg twice daily at 8am and 2 pm for 3 days And melatonin 10 MG at 8pm for 3 days. Pain perception will be checked at 24hrs, 48 hrs and 72 hrs after surgery using 10 POINT VAS scale. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Systemically healthy patient having generalized periodontitis needing periodontal flap surgery.

Patients willing to undergo flap surgery
Patients willing to participate in the study. 
 
ExclusionCriteria 
Details  Patients with known systemic disorders and under medication for the same.
Patients allergic to melatonin and/or ibuprofen
Patients with a history of anti-inflammatory and/or antibiotic therapy over the last six months
Patients with a history of periodontal therapy over the last six months
Pregnant and lactating mothers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain perception will be lesser in the intervention group (melatonin with ibuprofen chronotherapy) than in the comparator groups   Pain perception will be checked 24 hours, 48 hours and 72 hours after surgery.  
 
Secondary Outcome  
Outcome  TimePoints 
Adverse consequences after intervention therapy( melatonin with ibuprofen chronotherapy) will be lesser when compared to the comparator groups.  24 hours, 48 hours and 72 hours post surgery  
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "112"
Final Enrollment numbers achieved (India)="104" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/01/2023 
Date of Study Completion (India) 22/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 22/04/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A randomized control double blinded cross over trial will be conducted on 75 participants to find out the efficacy of melatonin with ibuprofen chronotherapy in reducing the pain perception after periodontal surgery and compare the results with that ibuprofen chronotherapy in reducing pain perception after periodontal surgery.  
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