| CTRI Number |
CTRI/2024/10/075371 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Alveolar ridge preservation techniques |
|
Scientific Title of Study
|
CLINICAL, HISTOLOGICAL AND RADIOGRAPHIC EVALUATION AFTER ALVEOLAR RIDGE PRESERVATION WITH PARTIALLY DEMINERALIZED DENTIN MATRIX AND PLATELET RICH FIBRIN VERSUS DEMINERALIZED FREEZE DRIED BONE ALLOGRAFT A RANDOMIZED CONTROLLED CLINICAL 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 ASMA KADRI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR ZIAUDDIN AHMED DENTAL COLLEGE AND HOSPITAL , ALIGARH MUSLIM UNIVERSITY , ALIGARH |
| Address |
DEPARTMENT OF PERIODONTIA AND COMMUNITY DENTISTRY OPD NO 2,DR ZIAUDDIN AHMED DENTAL COLLEGE AND HOSPITAL,ALIGARH MUSLIM UNIVERSITY,ALIGARH, UP, INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8700896041 |
| Fax |
|
| Email |
asmakadri23765@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF AFSHAN BEY |
| Designation |
PROFESSOR |
| Affiliation |
DR ZIAUDDIN AHMED DENTAL COLLEGE AND HOSPITAL , ALIGARH MUSLIM UNIVERSITY, ALIGARH |
| Address |
DEPARTMENT OF PERIODONTIA AND COMMUNITY DENTISTRY OPD NO 2,DR ZIAUDDIN AHMED DENTAL COLLEGE AND HOSPITAL,ALIGARH MUSLIM UNIVERSITY,ALIGARH, UP, INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837231654 |
| Fax |
|
| Email |
afshanbey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AFAF ZIA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
DR ZIAUDDIN AHMED DENTAL COLLEGE AND HOSPITAL , ALIGARH MUSLIM UNIVERSITY, ALIGARH |
| Address |
DEPARTMENT OF PERIODONTIA AND COMMUNITY DENTISTRY OPD 2,DR ZIAUDDIN AHMED DENTAL COLLEGE AND HOSPITAL,ALIGARH MUSLIM UNIVERSITY,ALIGARH, UP, INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897789011 |
| Fax |
|
| Email |
afafzia@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF PERIODONTIA AND COMMUNITY DENTISTRY OPD 2, DR ZIAUDDIN AHMED DENTAL COLLEGE AND HOSPITAL, ALIGARH MUSLIM UNIVERSITY, ALIGARH, INDIA 202002 |
|
|
Primary Sponsor
|
| Name |
DR ASMA KADRI |
| Address |
DR ZIAUDDIN AHMED DENTAL COLLEGE AND HOSPITAL, ALIGARH MUSLIM UNIVERSITY , ALIGARH, UP 2000202 |
| Type of Sponsor |
Other [SELF SPONSERED] |
|
|
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 |
| DR ASMA KADRI |
DR ZIAUDDIN AHMED DENTAL COLLEGE AND HOSPITAL , AMU, ALIGARH |
DEPARTMENT OF PERIODONTIA AND COMMUNITY DENTISTRY OPD NO 2 DR ZIAUDDIN AHMED DENTAL COLLEGE AND HOSPITAL,AMU, ALIGARH
Aligarh
UTTAR PRADESH |
8700896041
asmakadri23765@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Medical College and Hospital ,Faculty of Medicine Aligarh Muslim University ,Aligarh,U.P , India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alveolar ridge preservation with demineralized freeze dried bone allograft |
The clinical radiographic and histomorphometric analysis after alveolar ridge preservation with demineralized freeze dried bone allograft total duration of 2 years |
| Intervention |
Alveolar ridge preservation with partially demineralized dentin matrix combined with platelet rich fibrin |
Clinical,radiographic and histomorphometric analysis after alveolar ridge preservation with partially demineralized dentin matrix combined with platelet rich fibrin total duration of 2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient should be in good health
Patient with hopeless and non restorable tooth
Patient should desire to have implant restoration
Patient should be available for follow up |
|
| ExclusionCriteria |
| Details |
Any history of radiotherapy
History of systemic illness
History of smoking
History of past surgical treatment of accused tooth |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
CLINICAL OUTCOMES
RADIOGRAPHIC OUTCOMES
HISTOLOGIC OUTCOMES |
CLINICAL AND RADIOGRAPHIC OUTCOMES AT 1 WEEK AND 4 MONTHS
HISTOMORPHOMETRIC ANALYSIS AT 4 MONTHS FOLLOW UP
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
26/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The present study is to be conducted in the Department of Periodontics and community dentistry, in association with Department of Oral and Dental Pathology and Microbiology ZADCH AMU and Department of interdisciplinary biotechnology unit. A written consent is obtained from the patient visiting the department of periodontia and community dentistry Dr Ziauddin ahmed dental college and hospital |