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CTRI Number  CTRI/2024/04/065990 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 12/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of A-PRF and S-PRF on Postoperative Sequelae for Impacted Mandibular Third Molar Surgery 
Scientific Title of Study   Comparative study on effects of A-PRF and S-PRF on pain edema trismus soft tissue healing and bone healing following impacted lower third molar extraction-A randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VELOOR MANI BALAJI 
Designation  POST GRADUATE STUDENT  
Affiliation  GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE ,BANGALORE 
Address  Department of Oral and Maxillofacial Surgery, Room No-2B,Government Dental College and Research Institute, Victoria Hospital, near City Market, Kalasipalya, Bengaluru, Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9515737743  
Fax    
Email  drbalumds@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MAMTHASHRI 
Designation  ASSOCIATE PROFESSOR,DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY 
Affiliation  GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE ,BANGALORE 
Address  Department of Oral and Maxillofacial Surgery, Room No-2B, Government Dental College and Research Institute, Victoria Hospital, near City Market, Kalasipalya, Bengaluru, Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9972888088  
Fax    
Email  mamthashri15@gmail.com  
 
Details of Contact Person
Public Query  
Name  MAMTHASHRI 
Designation  ASSOCIATE PROFESSOR,DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY 
Affiliation  GOVERNMENT DENTAL COLLEGE AND RESEARCH INSTITUTE ,BANGALORE 
Address  Department of Oral and Maxillofacial Surgery, Room No-2B, Government Dental College and Research Institute, Victoria Hospital, near City Market, Kalasipalya, Bengaluru, Karnataka

Bangalore
KARNATAKA
560002
India 
Phone  9972888088  
Fax    
Email  mamthashri15@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College and Research Institute ,Bangalore 
 
Primary Sponsor  
Name  Veloor Mani Balaji 
Address  Dept of Oral and Maxillofacial Surgery, Room No-2B,GDCRI, Victoria Hospital, near City Market, Kalasipalya, Bengaluru, Karnataka 560002 
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 
Dr Veloor Mani Balaji  Government Dental College and Research Institute  Department of Oral and Maxillofacial Surgery, Room No-2B,Victoria Hospital, near City Market, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA 		 9515737743

drbalumds@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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 
Intervention  A-PRF(Advanced-Platelet Rich Fibrin)  A-PRF(Advanced -Platelet Rich Fibrin)in extracted third molar socket for 6 months 
Comparator Agent  S-PRF(Standard-Platelet Rich Fibrin)  S-PRF(Standard- Platelet Rich Fibrin)in extracted third molar socket for 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Healthy patients without significant medical diseases or a history of bleeding problems.
2.The third molars had to be in the Class I, Level A position (according to Pell &Gregory)
3.Impacted teeth to be in the mesioangular position according to Winter.
 
 
ExclusionCriteria 
Details  1.Pregnant and lactating women
2.Patients with signs of pericoronitis
3.Patients with chronic use of medications such as antihistamines, non steroidal anti inflammatory drugs (NSAID, steroids and antidepressants which would complicate the evaluation of their postoperative response. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Postoperative pain will be measured using a visual analogue scale (VAS).

2.Soft tissue healing will be assessed based on Landry and Turnbull scale.

3.Trismus will be evaluated by measuring the distance between incisal edges of upper and lower central incisor at maximal mouth opening.

4.Bone healing of the third molar socket will be assessed radiographically using an OPG/IOPAR.

5.Post-operative swelling will be assessed.


 		 1.Post Operative pain will be assessed at day 1, day 3 and day 7.

2.Post Operative swelling will be assessed at day 1, day 3 and day 7.

3.Post Operative trismus will be assessed at postoperative day 1, day 3 and day 7.

4.Soft tissue healing will be assessed on Postoperative Day 7.

5.Bone healing radiographically will be assessed on postoperative 1 month, 3 months and 6 months




 
 
Secondary Outcome  
Outcome  TimePoints 
The presence of alveolar osteitis will be assessed on the basis of clinical examination and subjective symptoms reported by the patient.  Assessment for alveolar osteitis will be done clinically at postoperative day 3 and 7. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   01/05/2024 
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="1"
Months="0"
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
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drbalumds@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Removal of the impacted third molars is the most common surgical procedure performed in outpatient setting. This procedure may be associated with considerable postoperative complications including pain, trismus, edema, surgical site infection as well as alveolar osteitis. To date numerous methods such as utilization of pharmacologic agents including corticosteroids, nonsteroidal anti-inflammatory drugs, hyaluronic acid, cold therapy, and piezo-electric devices have been used in an attempt to accelerate wound healing and prevent post-operative complications. However, the most effective method that provides optimum control in the post-operative period is still under debate.

Platelet concentrates acts as an immune regulator and may decrease the deleterious effects of inflammation as mentioned by Dohan et al. Advanced platelet-rich fibrin (A-PRF) a new formulation of PRF introduced by Choukroun showed a looser structure with more inter-fibrous space and more cells could be counted in the fibrin-rich clot. Furthermore, the cells were more evenly distributed throughout the clot, as compared to S-PRF, and some cells could even be found in the clot’s more distal parts. A-PRF had a greater number of  leukocyte and platelet as well as growth factors(VEGF and TGF-β1).Several clinical studies which explore the effect of PRF on postoperative sequelae following third molar surgery have shown promising effects of PRF on reducing post-operative oedema, trismus and pain ,few studies have been conducted on the efficacy of PRF and its modified forms on ossification of bone defects created by removal of teeth, however a lacuna exists on the use of PRF and its modified forms on soft tissue and bony healing following impacted third molar extractions 
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