| CTRI Number |
CTRI/2022/10/046295 [Registered on: 10/10/2022] Trial Registered Prospectively |
| Last Modified On: |
07/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Novel method for socket preservation using a resorbable magnesium-mesh incorporated collagen membrane. |
|
Scientific Title of Study
|
EVALUATION OF AN INNOVATIVE RESORBABLE MAGNESIUM-MESH INCORPORATED COLLAGEN MEMBRANE USED ALONE OR IN COMBINATION WITH DEMINERALIZED FREEZE-DRIED BONE ALLOGRAFT IN CASES OF SOCKET PRESERVATION: A LONGITUDINAL 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 Pooja Bhanushali |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Pacific Dental College and Hospital , Airport Road , Debari, Udaipur , Rajasthan - 313024
Pacific Dental College and Hospital , Airport Road , Debari, Udaipur , Rajasthan - 313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
7738644404 |
| Fax |
|
| Email |
poojabhanushali2420@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi mathur |
| Designation |
Professor |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Pacific Dental College and Hospital , Airport Road , Debari, Udaipur , Rajasthan - 313024
Pacific Dental College and Hospital , Airport Road , Debari, Udaipur , Rajasthan - 313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
9929826446 |
| Fax |
|
| Email |
draditimathur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Bhanushali |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Pacific Dental College and Hospital , Airport Road , Debari, Udaipur , Rajasthan - 313024
Pacific Dental College and Hospital , Airport Road , Debari, Udaipur , Rajasthan - 313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
7738644404 |
| Fax |
|
| Email |
poojabhanushali2420@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr. Pooja Bhanushali |
| Address |
pacific dental college and hospital , debari , udaipur- 313024 |
| Type of Sponsor |
Other [self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Self funded |
pacific dental college and hospital , debari , udaipur- 313024 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Bhanushali |
Pacific dental college and hospital |
Department of periodontics, Pacific dental college and hospital, Debari, Udaipur
Udaipur
RAJASTHAN |
7738644404
poojabhanushali2420@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pacific academy of higher education and research university |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Socket preservation |
1.Atraumatic extraction will be done.
2.Magnesium-mesh incorporated collagen membrane and DFDBA to be used in cases of socket preservation.
Radiographic Investigation: Intra oral periapical radiographs and cone beam computed tomography (CBCT) to be performed.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with atleast three teeth indicated for extractions.
2.Socket depth ≥ 5mm and width ≥ 3mm
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Subjects with intraoral periapical lesion.
3.Subjects with history of Magnesium allergy and subjects on bisphosphonates therapy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that the use of Magnesium-mesh incorporated collagen membrane will be beneficial for preserving alveolar crestal height.
|
Baseline , 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that the use of Magnesium-mesh incorporated collagen membrane will be beneficial for preserving socket fill. |
Baseline , 6 months |
|
|
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)
|
12/10/2022 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction – Socket preservation using barrier membranes or a combination of membranes with bone graft ensure that the alveolar ridge retains its dimension after extraction. Collagenous membranes are used as barrier membrane but has the disadvantage of collapse into the socket. Where Magnesium mesh being biocompatible and degradable can be combined with collagen membrane for additional volume stability. Objective - To radiographically evaluate the efficacy of an innovative Magnesium-mesh incorporated collagen membrane used alone or in combination with demineralized freeze-dried bone allograft in cases of socket preservation, over a period of 6 months. Methodology – The need for surgery and the outcome of it will be explained to the 10 patients with atleast 3 teeth indicated for extraction, following which a verbal and written consent will be obtained. Following extraction of teeth, Sockets will randomly divide into three groups- Group 1 -Magnesium-mesh incorporated collagen membrane alone. Group 2 -DFDBA with Magnesium-mesh incorporated collagen membrane. Group 3 –Spontaneous healing. Radiographic parameters to be assessed at baseline and after 6 months. CBCT evaluation of the socket fill and alveolar crestal height to be done using carestream CS 9300 machine. Proposed conclusion – It is expected that the use of Magnesium-mesh incorporated collagen membrane will be beneficial for preserving alveolar crestal height. |