| CTRI Number |
CTRI/2021/10/037055 [Registered on: 04/10/2021] Trial Registered Prospectively |
| Last Modified On: |
01/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the preservation of alveolar bone after tooth extraction by immediate bone grafting with amniotic membrane or collagen membrane |
|
Scientific Title of Study
|
Comparative evaluation of two bio-absorabable membranes on alveolar ridge dimensions in post extraction sites: A 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 |
Aabida Taslim |
| Designation |
Academic junior resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, IMS,
BHU, Varanasi- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7081354131 |
| Fax |
|
| Email |
aabidataslim1705@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika Bansal |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, IMS,
BHU, Varanasi- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9335499117 |
| Fax |
|
| Email |
drmonika97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aabida Taslim |
| Designation |
Academic junior resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, IMS,
BHU, Varanasi- 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7081354131 |
| Fax |
|
| Email |
aabidataslim1705@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aabida Taslim |
| Address |
Unit of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi-221005 |
| Type of Sponsor |
Other [Self Sponsoring] |
|
|
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 |
| Aabida Taslim |
Faculty of Dental Sciences IMS BHU |
Unit of Periodontology, Faculty of Dental Sciences, IMS, BHU, Varanasi-221005
Varanasi
UTTAR PRADESH |
7081354131
aabidataslim1705@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee IMS BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The tooth with endodontic failure or unable to restore from severe caries or crown/root fracture or mobility in maxilla or mandible which are going to be extracted |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluation of amniotic membrane in alveolar ridge dimensions in post extraction sites dimensional changes of alveolar ridge are measured immediately after extraction and graft placement and at 6th month later using RVG and stent. |
Atraumatic extraction technique are perform on selected tooth. Dimensional changes of alveolar ridge are measured immediately after extraction, amneotic membrane and bone graft placement and at 6th month later using RVG and stent. |
| Comparator Agent |
Evaluation of collagen membrane in alveolar ridge dimensions in post extraction sites dimensional changes of alveolar ridge are measured immediately after extraction and graft placement and at 6th month later using RVG and stent. |
Atraumatic extraction technique are perform on selected tooth.
Dimensional changes of alveolar ridge are measured immediately after extraction, collegen membrane and bone graft placement and at 6th month later using RVG and stent. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
-Physically, mentally, and systemically healthy patient.
-Indications for extracting tooth are including single-rooted teeth with
endodontic failure or unable to restore from severe caries or crown/ root fracture or mobility.
|
|
| ExclusionCriteria |
| Details |
1. Patients with compromised medical history.
2. Presence of dehiscence or fenestration or socket destruction
more than 50% of the alveolar bone wall of the socket after extraction
3. History of malignancy, radiotherapy, or chemotherapy for malignancy in
the past 5years.
4. Unwillingness to sign a consent form and return it for all follow-up periods.
5. Habits like smoking and chewing
6. Parafunctional habits
7. Traumatic occlusion
8. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Preservation of horizontal and vertical alveolar ridge dimension in all cases |
pre-op, post-op and at 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevention of width of keratinized tissue, height free gingival margin, soft tissue thickness, pain, redness and swelling in all cases |
pre-op, at 1st month ,at 3rd month and at 6th month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
09/10/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osseointegration and
longevity of implants depend on the quantity and quality of the alveolar ridge at
the time of implant placement. Tooth extraction is led by
alveolar bone resorption which rapidly begins and continues for years To eliminate or minimize extensive regenerative surgical procedures, the alveolar ridge
preservation (ARP) procedure is recommended to perform at the time of tooth extraction
to preserve the alveolar bone architecture. Alveolar ridge preservation can be achieved by immediately filling the undamaged tooth socket
with biomaterials. Different types of bone substitutions and membranes have been utilized for
socket augmentation. Our goal is to evaluate the efficacy of the amniotic membrane, as a new
material, on in comparison with the collagen membrane in the present study. In this study, prevention of alveolar bone resorption after tooth extraction by immediate bone
grafting with amniotic membrane or collagen membrane. |