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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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