| CTRI Number |
CTRI/2024/04/065101 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Assessment of bone formation ability of demineralized tooth matrix and injectable platelet rich fibrin flowable graft material using- An IN-vivo study |
|
Scientific Title of Study
|
Development and characterization of flow able mixture of demineralized tooth matrix and injectable platelet rich fibrin graft material for socket preservation and characterization of regenerated bone |
| 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 BH Harshitha Gowda |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Dental Sciences, MS Ramaiah university of applied sciences |
| Address |
Department of Prosthodontics and Crown and Bridge.
Faculty of Dental Sciences.
Ramaiah University of Applied Sciences. New BEL road. Bangalore
New BEL road. Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9980911059 |
| Fax |
|
| Email |
drharshithagowda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravishankar K |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences |
| Address |
Department of Prosthodontics and Crown and Bridge.
Faculty of Dental Sciences.
Ramaiah University of Applied Sciences. New BEL road. Bangalore
Department of Prosthodontics and Crown and Bridge.
Faculty of Dental Sciences.
Ramaiah University of Applied Sciences. New BEL road. Bangalore
KARNATAKA
560054
India |
| Phone |
9980911059 |
| Fax |
|
| Email |
docravi76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BH Harshitha Gowda |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Dental Sciences, MS Ramaiah university of applied sciences |
| Address |
Department of Prosthodontics and Crown and Bridge.
Faculty of Dental Sciences.
Ramaiah University of Applied Sciences. New BEL road. Bangalore
New BEL road. Bangalore
KARNATAKA
560054
India |
| Phone |
9980911059 |
| Fax |
|
| Email |
drharshithagowda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental sciences, MS Ramaiah University of applied sciences, New BEL road, Bangalore 54 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Investigator initiated study] |
|
|
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 Ravishankar K |
Faculty of Dental Sciences MS Ramaiah University of Health Sciences |
Department of Oral & Maxillofacial surgery, Room no 10, 2nd floor
Bangalore
KARNATAKA |
9886056303
docravi76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics committee for Human trials, MSRUAS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K082||Atrophy of edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Autogenous demineralized tooth matrix with Injectable platelet rich fibrin |
The tooth indicated for extraction due to periodontal disease is extracted and powdered, demineralized, washed & mixed with the same subject’s injectable platelet rich fibrin and placed into the extracted socket for socket preservation. Following the socket preservation the participant will be followed for Day 0, month 1 and month 3 to assess radiologically for bone regeneration. |
| Comparator Agent |
BIO-OSSE |
It is commercially available xenograft obtained from bovine collagen and is used extensively as a socket shield graft material in implantology. Following the socket preservation the participant will be followed for Day 0, month 1 and month 3 to assess radiologically for bone regeneration. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Teeth extracted for periodontal purpose (Grade 2 & 3 mobility) |
|
| ExclusionCriteria |
| Details |
Infected and decayed tooth and root canal treated tooth
2. Uncontrolled diabetes mellitus, Hypertension, Heavy smokers
3. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone formation in the tooth socket filled with autogenous graft and comparing with BIO-OSSE using cone beam computed tomography and if patients are willing to consent bone histological study after implant placement |
Baseline, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the bone formation between the study groups at the end of the study |
03 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drharshithagowda@gmail.com].
- For how long will this data be available start date provided 01-10-2024 and end date provided 30-09-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Rationale-Autogenous bone grafts are proven to be superior in comparison with other graft materials as there is no rejection. The reason for requirement of human patients in this study is, for the preparation of autogenous injectable graft using patient blood and extracted tooth (considered a biological waste)
Aim - To develop an optimal flow able mixture of demineralized tooth matrix and platelet rich fibrin graft material for socket preservation and characterize the regenerated bone
Methods- All participants willing to provide written informed consent will be recruited to the present study after fully explaining the study procedure in their own language. Extracted tooth is cleaned, soft tissue removed and dried. The tooth is demineralized partially with 0.6mol Hydrochloric acid and powdered using smart dentine grinder and washed again with Phosphate Buffered solution. The Injectable Platelet Rich Fibrin (IPRF) is prepared, mixed with the powdered tooth in 1:1 ratio and the prepared autogenous graft is placed in the extracted socket and sutured. The active control BIO-OSS is placed in the opposite extracted tooth socket. Cone beam tomography is obtained at baseline and at the end of the study (03 months). If the participant consents for implant placement, bone tissue will be subjected for histological evaluation. |