FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/07/070947 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 19/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing a gel containing 5 percent melatonin with platelet rich fibrin versus just platelet rich fibrin for treating bony defects a study using clinical and radiographic exam. 
Scientific Title of Study   Comparative evaluation of 5 percent Melatonin gel in combination with Platelet rich Fibrin and Platelet Rich Fibrin alone in the treatment of Intrabony defects: A Clinico-Radiographic 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  Dr. Surekha Rathod 
Designation  Professor and Guide 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Nagpur. 
Address  Department of Periodontics and Implant Dentistry Ranjeet Deshmukh Dental College and Research Centre, Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Surekha Rathod 
Designation  Professor and Guide 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Nagpur. 
Address  Department of Periodontics and Implant Dentistry Ranjeet Deshmukh Dental College and Research Centre, Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Surekha Rathod 
Designation  Professor and Guide 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Nagpur. 
Address  Department of Periodontics and Implant Dentistry Ranjeet Deshmukh Dental College and Research Centre, Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Source of Monetary or Material Support  
Ranjeet Deshmukh Dental College and Research Centre, Nagpur- 440019 
 
Primary Sponsor  
Name  None 
Address  None 
Type of Sponsor  Other [None] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surekha Rathod  Ranjeet Deshmukh Dental College and Research Centre, Nagpur  104, Department of Periodontics and Implant Dentistry.
Nagpur
MAHARASHTRA 		 9011071477

drsurekhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ranjeet Deshmukh Dental College and Research Centre Ethics Committee  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  5% melatonin in combination with PRF  One time 0.5-1 mL Local drug delivery at the site of intrabony defect. 
Comparator Agent  Standard Control  PRF- single time at the site of intrabony defect. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients with stage III periodontitis assessed by probing pocket depth (PPD) ≥ 6mm, interdental clinical attachment loss (CAL) ≥ 5mm.
2) Patients with intrabony defects in either maxillary or mandibular arch.
 
 
ExclusionCriteria 
Details  1) Patients with history of systemic diseases, allergies or drug usage.
2) Patients who have undergone periodontal treatment in previous 6 months.
3) Pregnant or lactating women.
4) Smokers, tobacco chewers and patients with poor oral hygiene index will be excluded from the study.
5) In addition, tooth with caries, mobility greater than grade II will be excluded.


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Bone fill  Baseline, 3 and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
1) To assess Clinical attachment loss (CAL), probing pocket depth (PPD) in intrabony defects when treated with 5% Melatonin gel in a combination with PRF at baseline, 3 months and 6 months postoperatively.
2) To assess Clinical attachment loss (CAL), probing pocket depth (PPD) in intrabony defects when treated with PRF alone at baseline, 3 months and 6 months postoperatively.
3) To assess radiographic bone fill obtained in intrabony defects when treated with 5% Melatonin gel in a combination with PRF at baseline and 6 months post operatively by Cone Beam Computed Tomography (CBCT).
4) To assess radiographic bone fill obtained in intrabony defects when treated with PRF alone at baseline and 6 months post operatively by Cone Beam Computed Tomography (CBCT).
 		 Baseline, 3 and 6 months. 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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/ Phase 4 
Date of First Enrollment (India)   23/08/2024 
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="11"
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  

Comparative evaluation of 5% Melatonin gel in combination with Platelet rich Fibrin and Platelet Rich Fibrin alone in the treatment of Intrabony defects: A Clinico-Radiographic Study.

Periodontitis is a chronic as well as multifactorial disease and if it left untreated then there are higher chances of destruction of periodontal apparatus which include, cementum, periodontal ligament and alveolar bone as a sequel of subgingival plaque accumulation which leads to inflammatory condition, caused by microbial infection and unbalanced host immune responses. 

Melatonin has been reported to promote osteoblastic differentiation and formation of a bone. Melatonin accelerates the synthesis of type I collagen fibers in human osteoblasts. It also improves the gene expression of bone sialoprotein, alkaline phosphatase, osteopontin, and osteocalcin in preosteoblasts. 

Choukroun et al described that platelet-rich fibrin (PRF), is a second-generation platelet concentrate incorporates platelets and growth factors within fibrin membranes. 

Previously very few evaluations were studied to detect 5% Melatonin gel in combination of PRF and PRF alone in the treatments of intrabony defects by Cone Beam Computed Tomography (CBCT). So this study is designed to evaluate and compare the efficacy of 5% Melatonin gel in combination with PRF and PRF alone in the amount of bone fill obtaining as a treatment modality in intrabony defects in Periodontitis by CBCT.

 


 
Close