| CTRI Number |
CTRI/2023/08/056065 [Registered on: 03/08/2023] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the gain in bone dimension of extraction socket after bone graft placement and without it |
|
Scientific Title of Study
|
Comparative evaluation of bone dimensional changes in extraction socket
after spontaneous healing and extraction socket preserved with demineralized
freeze dried bone allograft and autologous fibrin glue (sticky bone): 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 |
Mansi Sharma |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital |
| Address |
112, 1st floor, Department of Periodontology, Government Dental College and Hospital, Opposite police line, Navagam ghed, Jamnagar, 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9913450662 |
| Fax |
|
| Email |
mansisharma432@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nayana Patel |
| Designation |
PG Guide |
| Affiliation |
Government Dental College and Hospital |
| Address |
112, 1st floor, Department of Periodontology, Opposite police line, Navagam ghed, Jamnagar, 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9913450662 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mansi Sharma |
| Designation |
PG Student |
| Affiliation |
Government Dental College and Hospital |
| Address |
112, 1st floor, Department of Periodontology, Opposite police line, Navagam ghed, Jamnagar, 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9913450662 |
| Fax |
|
| Email |
mansisharma432@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Mansi Sharma |
| Address |
Government Dental College and Hospital, Opposite police line, Navagam ghed, Jamnagar, 361008 |
| 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 |
| Dr Mansi Sharma |
Government Dental College and Hospital, Jamnagar |
112, 1st floor, Deaprtment of Periodontology, Government Dental College and Hospital, Opposite police line, Navagam ghed, Jamnagar, 361008
Jamnagar
GUJARAT |
9913450662
mansisharma432@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee M. P. Shah Govt. Medical College & Guru Gobindsingh Hospital, Jamnagar |
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 |
collagen plug |
Commercially available as Fix Plug without any graft and allowed for spontaneous healing for time line of baseline to 6 months |
| Comparator Agent |
Sticky bone with collagen plug |
Sticky bone prepared from Demineralized Freeze Dried Bone Allograft and Autologous Fibrin Glue obtained from patients blood and compared from time line of baseline to 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Extraction of at least two teeth which are not adjacent to each other (root pieces,
severe decay, inability to restore, root fracture, periodontal disease, failed endodontic
treatment)
Only anterior teeth and premolar teeth are to be included
Radiographic bone height of ≥ 4 mm at site intended for surgery |
|
| ExclusionCriteria |
| Details |
Patients with acute periapical or periodontal infections.
Inability to maintain adequate oral hygiene. (Full mouth plaque level of more than
30%).
Any medical condition that contraindicated surgery. (Uncontrolled systemic diseases).
History of malignancy, radiotherapy, or chemotherapy.
Pregnancy or lactation
Absence of one or two adjacent teeth.
Smokers
Unwillingness to return for follow – up examination |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in buccolingual/ palatal width of alveolar ridge
Changes in vertical height of alveolar ridge
Bone density |
Baseline
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in probing depth (PD) at teeth adjacent to the
extraction site
Changes in clinical attachment level (CAL) at teeth adjacent to the extraction site |
Baseline
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/08/2023 |
| Date of Study Completion (India) |
01/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
TITLE OF THE STUDY: Comparative evaluation of bone dimensional changes in extraction socket after spontaneous healing and extraction socket preserved with demineralized freeze dried bone allograft and autologous fibrin glue (sticky bone): A randomized controlled clinical trial AIM AND OBJECTIVE: To compare the clinical and radiographic effects of demineralized freeze dried bone allograft and autologous fibrin gel (sticky bone) in alveolar socket preservation after tooth extraction compared with extraction alone. TYPE OF STUDY: A randomized controlled clinical trial 30 such cases will be included in the study meeting the inclusion criteria. Sample will be divided into two groups 1) Control group Atraumatic extraction with collagen plug 2) Test group Atraumatic extraction with sticky bone and collagen plug. Followed by extraction cross mattress suture will be taken in both groups. Clinical assessment done after 1 week followed by suture removal. Clinical and radiographic parameters will be evaluated at baseline and 6 months interval. Collected data will be analyzed using t-test. |