| CTRI Number |
CTRI/2025/08/093278 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of dentine graft vs Platelet rich fibrin in third molar extraction socket healing |
|
Scientific Title of Study
|
Comparative Evaluation of outcome of dentin graft as
against Plasma Rich Fibrin in post operative impacted mandibular third molar bony in defects- A split mouth technique. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Suvarna Dixit |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
004, Department of Oral and Maxillofacial Surgery, SPDC Building, Sawangi Meghe
004, Department of Oral and Maxillofacial Surgery, SPDC Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9521873975 |
| Fax |
|
| Email |
diva.dixit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhushan Mundada |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of higher education and Research |
| Address |
004, Department of Oral and Maxillofacial Surgery, SPDC Building, Sawangi Meghe
004, Department of Oral and Maxillofacial Surgery, SPDC Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975629137 |
| Fax |
|
| Email |
pbmundada18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhushan Mundada |
| Designation |
Associate professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
004, Department of Oral and Maxillofacial Surgery, SPDC Building, Sawangi Meghe
004, Department of Oral and Maxillofacial Surgery, SPDC Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975629137 |
| Fax |
|
| Email |
Pbmundada18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta meghe institute of higher education, DMIHER, Sawangi, Wardha, Maharastra. India 442001 |
|
|
Primary Sponsor
|
| Name |
Divya Suvarna Dixit |
| Address |
Sharda , DMIHER campus, Sawangi Wardha, Maharastra India 442001 |
| Type of Sponsor |
Other [self] |
|
|
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 Divya Suvarna Dixit |
Sharad Pawar Dental College And Hospital, DMIHER |
004, Oral and Maxillofacial Surgery , SPDC Building, sawangi Meghe
Wardha
MAHARASHTRA |
9521873975
diva.dixit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee, Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K11||Diseases of salivary glands, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: K118||Other diseases of salivary glands, (4) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dentine Graft |
A Dentine Graft will be made from the extracted tooth and will be placed in the extraction socket for better socket healing, less swelling, and less pain |
| Comparator Agent |
PRF |
PRF will be made from the patients blood and will be placed in the third molar extraction socket to compare the healing with the Dentine Graft |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Impacted bilateral mandibular third molar indicated for extraction |
|
| ExclusionCriteria |
| Details |
All patients who are not willing to be a part of study
• All patients with uncontrolled systemic diseases.
- Patients with Diabetes Mellitus, Coronary Artery Disease, Peripheral Vascular Diseases & Cancer.
- Patients on Long term Corticosteroid therapy.
- Patients with immunocompromised status.
- Pregnant and Lactating females
- Patients with peri apical infections and cyst
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
postoperative
Swelling
Pain
Bone Density
Soft tissue healing
|
2 day, 3 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Volume of socket and bone regeneration. |
3 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="9"
Sample Size from India="9"
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)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
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
|
By preventing the alveolar ridge from atrophying, socket and ridge preservation procedures make it possible for functional and aesthetically pleasing restorations. The main goal of alveolar management following tooth extraction is to keep the alveolar socket’s volume intact to avoid significant resorption and promotes socket healing. Numerous methods have been reported to keep the socket healing as following tooth extractions. Osteogenesis, osteoinduction, and osteoconduction are three different ways that grafting materials might encourage the socket’s healing after extraction. |