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CTRI Number  CTRI/2020/12/029599 [Registered on: 04/12/2020] Trial Registered Prospectively
Last Modified On: 16/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   assessment of bone healing after endodontic surgery using two bioresorbable membranes  
Scientific Title of Study   comparative assessment of periapical bone healing after endodontic microsurgery using GTR bioabsorbable membrane with and without PRF: A prospective randomized controlled trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Surendra Kumar Mishra 
Designation  Professor and Chairman 
Affiliation  Professor and Chairman 
Address  Department of Conservative Dentistry and Endodontics Dr Ziauddin Ahmad Dental College and Hospital AMU, Aligarh
HIG II41 Swarn jayanti nagar Ramghat Road, Aligarh 202001
Aligarh
UTTAR PRADESH
202001
India 
Phone  9358203449  
Fax    
Email  drsurendrakmishra69@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  sharique alam 
Designation  Assistant Professor 
Affiliation  Assistant Professor 
Address  Department of conservative dentistry and endodontics Dr Ziauddin Ahmad Dental College and Hospital, AMU Aligarh
flat no 202 Posh residency hadi nagar dhorrah aligarh 202002
Aligarh
UTTAR PRADESH
202001
India 
Phone  8791298399  
Fax    
Email  sharique2004@gmail.com  
 
Details of Contact Person
Public Query
 
Name  disha mahore 
Designation  JUNIOR RESIDENT 
Affiliation  JUNIOR RESIDENT 
Address  Dr Ziauddin Ahmad Dental College and Hospital
room no 916, gulzar residency, medical road, Aligarh 202001
Aligarh
UTTAR PRADESH
202001
India 
Phone  07507741889  
Fax    
Email  mahoredisha@gmail.com  
 
Source of Monetary or Material Support  
Department of Conservative Dentistry and Endodontics Dr Z.A dental college aligarh muslim university Aligarh Uttar Pradesh 202001 
 
Primary Sponsor  
Name  Department of Conservative Dentistry and Endodontics 
Address  Department of Conservative Dentistry Dr Z.A Dental College Aligarh Muslim University  
Type of Sponsor  Government medical college 
 
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 
disha mahore  Dr Ziauddin ahmed dental college and hospital  Dr Ziauddin ahmed dental college and hospital,AMU,medical road Department of conservative dentistry and endodontics Aligarh
Aligarh
UTTAR PRADESH 
7507741889

mahoredisha@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1)GTR with PRF 2)GTR without PRF   Periapical surgery will be conducted and the surgical window will be restored by placing either 1)GTR with PRF 2)GTR without PRF and 3. Blood clot based on the randomised allotment. The Intervention will be carried out after completely curetting the defect from the periapical site.The healing of periapical bone will be assessed by radiographs using Periapical Index Scoring during the follow up of 0,3,6,9,12 months Frequency- Intervention will be conducted once during surgery and follow up healing assessed at 0,3,6,9,12 months Route of administration - Surgical Intervention Total Duration - The healing of bone will be followed up at 0,3,6,9,12 months 
Comparator Agent  Blood clot  The bony defect after the periapical surgery will be allowed to fill with blood clot without any intervention of additional Guided tissue Regenerative procedure. The healing of the Perapical area will be assessed during the follow up period of 0,3,6,9,12 months  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  negative response to vitality tests with radiographic evidence of periapical radiolucencies 
 
ExclusionCriteria 
Details  pathology amenable to healing by NSRCT, clinical or radiographic evidence of vertical root fracture, teeth with an earlier history of endodontic surgery, uncooperative patient or patient with a compromised medical history for an oral surgical intervention including uncontrolled diabetes and tuberculosis  
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
effect of GTR with PRF,GTR without PRF, and nomal blood clot on periapical healing  3,6,9,12 months 
 
Secondary Outcome  
Outcome  TimePoints 
effect of early or late periapical healing in between 3 groups
and comparison of periapical healing between group 1 and group 2 and also with inter group comparison 
3,6,9,12 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2021 
Date of Study Completion (India) 28/01/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The primary goal of endodontic surgery is to eliminate periradicular pathology and aid regeneration of the periapical tissues including the complete healing of osseous defects. Apico-marginal defects are localized bony defects that include the entire length of the root i.e., defect which extends from the periapex to the alveolar crest to the tooth. This defect caused by combined periodontal-endodontic lesion or an endodontic-periodontal lesion. The treatment of endodontic-periodontal combined lesions requires both endodontic therapy and periodontal regenerative procedure. Advancement in newer guided tissue regeneration technique and development of second-generation platelet concentrate, platelet rich fibrin shows promising result in field of endodontic surgery. PRF promotes healing of wound, flap stabilization, osseous growth and hemostasis. The present study assess the one-year postoperative healing outcome of Apico-marginal bone defects treated by endodontic microsurgery using two guided regenerative technique. The GTR technique compared included placement of a collagen membrane with and without the adjunctive utilization of PRF over the apico-marginal and osseous defect before flap closure after performing endodontic microsurgery.

 
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