| CTRI Number |
CTRI/2020/06/025576 [Registered on: 03/06/2020] Trial Registered Prospectively |
| Last Modified On: |
27/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
STUDYING THE ROLE OF BIOLOGICAL MEMBRANES IN BONE HEALING AFTER TOOTH APEX SURGERY BY USING COLOR DOPPLER ULTRASOUND |
|
Scientific Title of Study
|
ROLE OF AMNIOTIC MEMBRANE AND PLATELET RICH FIBRIN IN BONE HEALING POST ENDODONTIC SURGERY: A COLOR DOPPLER SONOGRAPHY STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SAUMYA JOHRI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,FIRST FLOOR, OLD DENTAL BUILDING
FACULTY OF DENTAL SCIENCES
KING GEORGES MEDICAL UNIVERSITY
CHOWK
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9452901970 |
| Fax |
|
| Email |
saumya.johry@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PROMILA VERMA |
| Designation |
PROFESSOR |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,FIRST FLOOR, OLD DENTAL BUILDING
FACULTY OF DENTAL SCIENCES
KING GEORGES MEDICAL UNIVERSITY
CHOWK
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7007789709 |
| Fax |
|
| Email |
promilarajesh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SAUMYA JOHRI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPT OF CONSERVATIVE DENTISTRY AND ENDODONTICS,FIRST FLOOR, OLD DENTAL BUILDING
FACULTY OF DENTAL SCIENCES
KING GEORGES MEDICAL UNIVERSITY
CHOWK
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9452901970 |
| Fax |
|
| Email |
saumya.johry@gmail.com |
|
|
Source of Monetary or Material Support
|
| RESEARCH CELL COMMITTEE KING GEORGES MEDICAL UNIVERSITY
LUCKNOW UTTARPRADESH (MONETARY) |
| TATA MEMORIAL HOSPITAL
PAREL
MUMBAI MAHARASHTRA (MATERIAL) |
|
|
Primary Sponsor
|
| Name |
DR SAUMYA JOHRI |
| Address |
DEPT OF CONSERVATIVE DENTISTRY AND ENDODONTICS FIRST FLOOR OLD DENTAL BUILDING FACULTY OF DENTAL SCIENCES KING GEORGES MEDICAL UNIVERSITY LUCKNOW UTTAR PRADESH |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR PROMILA VERMA |
Department of Conservative Dentistry and Endodontics,
Faculty of Dental Sciences
King George’s Medical University, Lucknow
Uttar Pradesh 226003
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SAUMYA JOHRI |
DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS |
FIRST FLOOR OLD DENTAL BUILDING FACULTY OF DENTAL SCIENCES KING GEORGES MEDICAL UNIVERSITY
Lucknow
UTTAR PRADESH |
9452901970
saumya.johry@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee king george medical university lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K045||Chronic apical periodontitis, (2) ICD-10 Condition: K046||Periapical abscess with sinus, (3) ICD-10 Condition: K047||Periapical abscess without sinus, (4) ICD-10 Condition: K048||Radicular cyst, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FREEZE DRIED AMNIOTIC MEMBRANE WITH SYNTHETIC HYDOXYAPATITE BONE GRAFT |
BONY CAVITY FORMED AFTER CURETTAGE OF PERI APICAL GRANULATION TISSUE/CYST WILL BE FILLED WITH HYDROXYAPATITE BONE GRAFT OVER WHICH AMNIOTIC MEMBRANE WILL BE PLACED |
| Comparator Agent |
PLATELET RICH FIBRIN WITH SYNTHETIC HYDROXYAPATITE BONE GRAFT |
BONY CAVITY FORMED AFTER CURETTAGE OF PERI APICAL GRANULATION TISSUE/CYST WILL BE FILLED WITH HYDROXYAPATITE BONE GRAFT OVER WHICH PLATELET RICH FIBRIN MEMBRANE WILL BE PLACED |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Single rooted, anterior teeth.
Non-surgical re-treatment cases showing signs of failure like pain, swelling, sinus, pus discharge, etc.
Patients who are not on any systemic medication affecting periapical healing
|
|
| ExclusionCriteria |
| Details |
Patients having insufficient motivation and capablility of reporting back for follow up visits to the clinics.
Patients with any systemic diseases like Diabetes Mellitus, Hypertension, Hepatitis, HIV, bone disorders etc.
Surgical retreatment cases.
Patients with malignant tumors or undergoing chemotherapy/radiotherapy.
Pregnant females.
Uncooperative patients.
Periodontally compromised teeth.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1-Percentage reduction in the size of periapical lesion
2-Percentage change in blood velocity of periapical lesions |
1 month after endodontic surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-Percentage reduction in the size of periapical lesion
2-Percentage change in blood velocity of periapical lesions |
3 months after endodontic surgery |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2020 |
| Date of Study Completion (India) |
01/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The current study is a randomised, double blinded, parallel group, single center study. The study will be done in the Department of Endodontics and Department of Radiodiagnosis of KGMU, Lucknow. Primary objective is to evaluate the efficacy of freeze dried, gamma irradiated amniotic membrane(AM) in bone healing after periapical endodontic surgery and to compare it with autologous platelet rich fibrin membrane (PRF) that is one of the accepted standard treatment for regenerative procedures of oral cavity. Evaluation will be done using ultrasound and color doppler imaging technique.
Amniotic membrane will be availed from tisuue bank of Tata Memorial Hospital, Mumbai; while PRF will be made from patient’s own blood using a PRF centrifuge machine in the department itself.
The primary outcomes of the study are- 1)Percentage reduction in the size of the periapical lesion(surgical site) after bony curettage.
2)Percentage change in peak systolic velocity of blood, showing change in vascularity of the treated lesion.
Time points of evaluation are baseline, 1 month and 3 months after surgery.
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