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CTRI Number  CTRI/2023/12/060959 [Registered on: 29/12/2023] Trial Registered Prospectively
Last Modified On: 27/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between two types of materials for treatment of bone defects present in between teeth 
Scientific Title of Study   Comparative evaluation of Enamel matrix derivative (Emdogain) with demineralised freeze dried bone allograft (DFDBA) for the treatment of Intrabony defects - A Randomised Controlled 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  Dr Renuka Metgud 
Designation  Professor 
Affiliation  Department of Periodontics, Room No. 9, KAHER KLE VK Institute of Dental Sciences 
Address  Department of Periodontics, Room No. 9, KAHER KLE VK Institute of Dental Sciences

Belgaum
KARNATAKA
590010
India 
Phone  9448920880  
Fax    
Email  renukametgud@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Renuka Metgud 
Designation  Professor 
Affiliation  Department of Periodontics, Room No. 9, KAHER KLE VK Institute of Dental Sciences 
Address  Department of Periodontics, Room No. 9, KAHER KLE VK Institute of Dental Sciences


KARNATAKA
590010
India 
Phone  9448920880  
Fax    
Email  renukametgud@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Renuka Metgud 
Designation  Professor 
Affiliation  Department of Periodontics, Room No. 9, KAHER KLE VK Institute of Dental Sciences 
Address  Department of Periodontics, Room No. 9, KAHER KLE VK Institute of Dental Sciences


KARNATAKA
590010
India 
Phone  9448920880  
Fax    
Email  renukametgud@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontics, Room No. 9, KAHER KLE VK Institute of Dental Sciences, Belagavi 
 
Primary Sponsor  
Name  Dr Renuka Metgud 
Address  Department of Periodontics, Room No. 9, KAHER KLE VK Institute of Dental Sciences, Belagavi 
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 
Dr Renuka Metgud  KAHER KLE VK Institute of Dental Sciences, Belagavi  Department of Periodontics, Room No. 9, KAHER KLE VK Institute of Dental Sciences, Belagavi
Belgaum
KARNATAKA 		 9448920880

renukametgud@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research and ethics committee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Demineralized Freeze Dried Bone allograft (DFDBA)  Flap surgery followed by placement of Demineralized Freeze Dried Bone allograft (DFDBA) in Intrabony defects for periodontal regeneration. 
Intervention  Enamel matrix derivative (EMD)  Flap surgery followed by placement of EMD in intrabony defects for periodontal regeneration 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Contained defects were included.
2. A full-mouth plaque score ≤ 20% at the time of the surgical procedure.
3. Probing depth (PD) ≥ 6 mm and an associated intrabony defect with a depth of ≥ 3 mm as measured on the periapical radiograph
 
 
ExclusionCriteria 
Details  1. Systemic diseases contraindicating periodontal surgery
2. Medications affecting periodontal status
3. Pregnancy or lactation
4. Smoking habits
5. Third molars and teeth with inadequate endodontic treatment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-Radiographic Bone Fill (RBF %)
-Clinical Attachment Level gain 		 Baseline and 3 months post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
-Plaque score
-Periodontal Pocket Depth (PPD) 		 Baseline and 3 months post operatively 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   15/01/2024 
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="6"
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   Periodontal regeneration is the restoration of the lost periodontium or supporting tissues which includes formation of new alveolar bone, new cementum and new periodontal ligament. Enamel Matrix Derivative(EMD) is a biological agent capable of periodontal regeneration. it has been demonstrated that EMD exerts a significant influence on cell behaviour of many cell types by mediating cell attachment, spreading, proliferation, differentiation. It plays a significant role in changing OPG/RANKL balance by increasing OPG and decreasing RANKL levels resulting in diminished osteoclast formation and activity. DFDBA is a bone graft material assumed to induce bone formation due to the influence of bone inductive proteins called BMPs which help in osteogenesis and bone formation.


 
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