FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/089580 [Registered on: 25/06/2025] Trial Registered Prospectively
Last Modified On: 19/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation and Comparison of Postoperative outcome of intra socket placement of Platelet Rich Fibrin with and without Collagen Plug in Extraction Socket of Impacted Mandibular Third Molar. 
Scientific Title of Study   Evaluation and Comparison of Postoperative outcome of intra socket placement of Platelet Rich Fibrin with and without Collagen Plug following removal of Impacted Mandibular Third Molar - A Split Mouth 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  Harsha Sinha 
Designation  Junior Resident(Post Graduate Trainee) 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Room No. 004, Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7390934540  
Fax    
Email  harshasinha1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajanikanth Kambala 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Room No. 004, Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8888839380  
Fax    
Email  rajanikanthmalaviya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajanikanth Kambala 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Room No. 004, Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe), Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  8888839380  
Fax    
Email  rajanikanthmalaviya@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe), Wardha, Maharashtra, India, Pin Code- 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research 
Address  Datta Meghe Institute of Higher Education and Research Campus, Sawangi(Meghe), Wardha, Maharashtra, India, Pin Code- 442001 
Type of Sponsor  Private medical college 
 
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 
HARSHA SINHA  Sharad Pawar Dental College  Room No. 004, Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe), Wardha, Maharashtra, India, Pin Code- 442001
Wardha
MAHARASHTRA 		 7390934540

harshasinha1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Platelet Rich Fibrin  Platelet Rich Fibrin would be inserted into the impacted mandibular 3rd molar extraction socket to assess post operative outcomes in patients. Total duration of intervention would be 3 months. 
Intervention  Platelet Rich Fibrin with Collagen Plug   Platelet Rich Fibrin with Collagen Plug would be inserted into the impacted mandibular 3rd molar socket to assess post operative outcomes in patients. Total duration of intervention would be 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients indicated for Surgical Extraction of Impacted bilateral mandibular third molar
2.A medical history devoid of any Pharmacology therapy able to introduce variable into experiments
 
 
ExclusionCriteria 
Details  1.All patients with uncontrolled systemic diseases.
2.Patients who are allergic to materials used during procedure.
3.Patients with Diabetes Mellitus, Coronary Artery Disease, Peripheral Vascular Diseases & Cancer.
4.Patients on Long term Corticosteroid therapy.
5.Patients with immunocompromised status.
6.Pregnant and Lactating females
7.Patients with peri apical infections or cyst involving mandibular third molar
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Less post operative pain, Better post operative soft tissue healing and bone regeneration  Assessment will be done on Post operative Day 1, Day 3, Day 7, Day 14 and after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduced Post operative Swelling  Assessment will be done on Post operative Day 1, Day 3, Day 7 
 
Target Sample Size   Total Sample Size="11"
Sample Size from India="11" 
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)   30/07/2025 
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="2"
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 - NO
Brief Summary  

Background

Impacted mandibular third molars are frequently encountered in dental practice, often due to limited space between the second molar and the mandibular ramus. Their removal can lead to complications such as bone loss, pain, swelling, periodontal issues, and delayed healing of adjacent structures.

Platelet Rich Fibrin PRF: An autologous healing aid rich in growth factors that enhance tissue repair through angiogenesis, collagen formation, and cellular activity. However, its preparation requires expensive centrifugation equipment.

Collagen Plug: A bioabsorbable scaffold that enhances tissue healing and bone regeneration. It is easy to use and helps maintain the integrity of the socket post-extraction.

Aim

To evaluate and compare the postoperative effects of intra-socket placement of PRF with and without a collagen plug after removal of impacted mandibular third molars.

Objectives

To evaluate PRF alone in terms of

  1. Pain
  2. Swelling
  3. Soft tissue healing
  4. Bone regeneration    
To evaluate PRF and Collagen Plug for the same postoperative outcomes.
To compare both groups to assess which approach leads to improved healing and regeneration


METHOD

This is a prospective randomized split-mouth clinical study comparing healing outcomes after impacted mandibular third molar extraction using Platelet Rich Fibrin  alone versus Platelet Rich Fibrin combined with a collagen plug. Key parameters assessed include pain, swelling, soft tissue healing, and bone regeneration. The goal is to determine whether the addition of a collagen plug enhances postoperative healing compared to PRF alone.

 
Close