| CTRI Number |
CTRI/2025/06/089782 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparsion of healing in first mandibular molar with and without platelet rich fibrin |
|
Scientific Title of Study
|
A Clinical And Radiographical Comparsion Of Healing In The Extraction Socket Of The Mandibular First Molar With And Without The Use Of Platelet Rich Fibrin (PRF)-A Prospective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yash Ajmera |
| Designation |
RESIDENT DOCTOR |
| Affiliation |
Governemt dental college and hospital |
| Address |
Government dental college and hospital Pathika ashram road navagam ghed Department of Oral and maxillofacial Surgery Room No.4 Pathika ashram road navagam ghed Department of Oral and maxillofacial Surgery Room No.4 Jamnagar GUJARAT 361008 India |
| Phone |
09723565029 |
| Fax |
|
| Email |
ajmerayash4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rajbir Randhawa |
| Designation |
Head of Department |
| Affiliation |
Governemt dental college and hospital |
| Address |
Government dental college and hospital Pathika ashram road navagam ghed Department of Oral and maxillofacial Surgery Room No.4 Pathika ashram road navagam ghed Department of Oral and maxillofacial Surgery Room No.4 Jamnagar GUJARAT 361008 India |
| Phone |
0 9065999990 |
| Fax |
|
| Email |
dr.rrandhawa23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Yash Ajmera |
| Designation |
RESIDENT DOCTOR |
| Affiliation |
Governemt dental college and hospital |
| Address |
Government dental college and hospital Pathika ashram road navagam ghed Department of Oral and maxillofacial Surgery Room No.4 Pathika ashram road navagam ghed Department of Oral and maxillofacial Surgery Room No.4 Jamnagar GUJARAT 361008 India |
| Phone |
09723565029 |
| Fax |
|
| Email |
ajmerayash4@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
YASH AJMERA |
| Address |
Department of oral and maxillofacial surgery government dental college and hospital pathik ashram road khed,jamnagar |
| 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 |
| DrYash Ajmera |
Government Dental College And Hospital Jamnagar |
Government dental college and hospital Pathika ashram road navagam ghed Department of Oral and maxillofacial Surgery Room No.4
Pathika ashram road navagam ghed Department of Oral and maxillofacial Surgery Room No.4 Jamnagar GUJARAT |
09723565029
ajmerayash4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHREE MP SHAH GOVERNMENT MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, (2) ICD-10 Condition: K04||Diseases of pulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healing will be evaluated after extraction of mandibular 1st molar |
Extraction of mandibular 1st molar using closed method will be done and healing will evaluated using clinical with the vernier clapier bucco- lingual width healing socket will be measured and radiographic parameters by taking rvg with position indicating device and grid and bone height will be measured compared to mesial and distal bone |
| Intervention |
Healing will be evaluated of mandibular 1st molar after applying platelet rich fibrin in extraction socket |
Extraction of mandibular 1st molar will be done using closed technique and platelet rich fibrin will be applied in extraction socket and healing will be checked clinical with the vernier clapier bucco- lingual width of healing socked will be measured and radiographic parameters by taking rvg with position indicating device and grid to check bone height compared to mesial and distal bone visible |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Age from 20 - 65 years
2 Only the first mandibular molar cannot be restored if the patient is unwilling to restore it.
3 Patients without any habits like smoking, tobacco chewers, or anything that can hinder the healing process.
4 Patients who are willing to give informed consent for the procedure.
5 Patients who are willing to agree to adhere to the study protocols.
6 Patient with platelet count more than 1.5×103/mm3
|
|
| ExclusionCriteria |
| Details |
1 Medically compromised patient
2 Patients with poor oral hygiene and periodontally compromise
3 Patient who will undergo trans alveolar extraction.
4 Patient cannot adhere to the schedule or is unwilling to give written consent.
|
|
|
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 and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the Bucco-Lingual of the alveolar ridge at baseline and three-month
2) Alevolar bone height at baseline and three months using radiograph. |
At base line and 12 weeks later buccolingual width of socket and bone height will be evaluated |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
03/06/2026 |
| 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="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Tooth extraction is a standard dental procedure used to manage various dental conditions. (Buchwald) The healing process after extraction is a complex series of bone cell migrations and maturation, leading to selective bone resorption and formation. This process reduces a dimensional alveolar ridge in horizontal and vertical directions. Replacing missing teeth, especially with implants, becomes more challenging due to the loss of necessary bone volume for successful implant placement. This post-extraction bone loss often requires bone grafting procedures to restore function and aesthetics reliably. Our study aims to shed light on this complex process and potentially offer a solution to the associated challenges. Various procedures prevent post-extraction bone loss and ensure predictable implant placements, including socket preservation with grafts (biomaterials) and immediate or early implant placements. While clinicians have a range of graft materials to choose from, some bone graft materials require longer healing time to achieve even a small amount of new bone incorporation into the graft site (Norton and Wilson, 2002). Platelet-rich fibrin (PRF) is a material derived from autologous blood preparation and is known for its exceptional ability to promote bone healing and regeneration. It acts as a scaffold and filler material due to its 3-dimensional structure, attracting and enriching various types of cells to migrate and proliferate here and accommodate them for extended periods. It contains multiple growth factors that can affect the expression of osteogenic genes, promote the metastasis and differentiation of mesenchymal stem cells, inhibit the generation of osteoclasts, and promote angiogenesis to achieve bone regeneration. Our study aims to harness this potential of PRF, adding it into the extraction socket and evaluating soft and hard tissue healing. |