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
|
|
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
|
|
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.
|