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CTRI Number  CTRI/2025/08/093848 [Registered on: 28/08/2025] Trial Registered Prospectively
Last Modified On: 16/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Evaluating soft tissue healing in smokers following use of concentrated growth factor in 3rd molars extraction socket  
Scientific Title of Study   Efficacy of Concentrated Growth Factor (CGF) in enhancing soft tissue healing in active smokers. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anamika B S 
Designation  Post graduate in Oral and Maxillofacial Surgery  
Affiliation  PMS College of Dental Science and Research  
Address  Department of Oral and Maxillofacial Surgery PMS College of Dental Science and Research Vattapara Trivandrum
Department of Oral and Maxillofacial Surgery PMS College of Dental Science and Research Vattapara Trivandrum
Thiruvananthapuram
KERALA
695028
India 
Phone  8547582366  
Fax    
Email  anamikarockview@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr YESHASWINI THELEKKAT  
Designation  Professor , Department of Oral and Maxillofacial Surgery  
Affiliation  PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH 
Address  Department of Oral and Maxillofacial Surgery PMS College of Dental Science and Research Vattapara Trivandrum
Department of Oral and Maxillofacial Surgery PMS College of Dental Science and Research Vattapara Trivandrum
Thiruvananthapuram
KERALA
695028
India 
Phone  8137011166  
Fax    
Email  yeshas26575@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  ANAMIKA B S 
Designation  Post graduate in Oral and Maxillofacial Surgery  
Affiliation  PMS ollege of Dental Science and Research  
Address  Department of Oral and Maxillofacial Surgery PMS College of Dental Science and Research Vattapara Trivandrum
Department of Oral and Maxillofacial Surgery PMS College of Dental Science and Research Vattapara Trivandrum
Thiruvananthapuram
KERALA
695028
India 
Phone  8547582366  
Fax    
Email  anamikarockview@gmail.com  
 
Source of Monetary or Material Support  
PMS College of Dental Science and Research Vattapara Trivandrum Kerala India 695028 
 
Primary Sponsor  
Name  Anamika B S  
Address  PMS College of Dental Science and Research Vattapara Trivandrum Kerala India 695028 
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 Anamika B S   PMS College of Dental Science and Research   Department of Oral and Maxillofacial Surgery
Thiruvananthapuram
KERALA 
8547582366

anamikarockview@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee certificate   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients presenting with impacted mandibular 3rd molars 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients over 18 years of age who need to undergo surgical removal of mandibular third molars and at risk of developing alveolar osteitis.
1) Patients classified ASA I and ASA II
2) Active smokers
3) Consenting for the study  
 
ExclusionCriteria 
Details  1) Patients aged less than 18 years
2) Immunocompromised patients
3) Patients with active infection
4) Pregnant females
5) Patients with history of blood dyscrasias 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of concentrated growth factor in enhancing soft tissue healing after surgical removal of mandibular 3rd molars in active smokers  4th day,10th day 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of concentrated growth factor in reducing the incidence of alveolar osteitis after surgical removal of mandibular 3rd molars in active smokers   4th day 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2025 
Date of Study Completion (India) 27/02/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/02/2026 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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)  
The purpose of this research is to evaluate the efficacy of concentrated growth factor  in promoting soft tissue healing and preventing alveolar osteitis in active smokers.
Patients reporting to the outpatient department of PMS College of Dental Science and Research indicated for surgical extraction of mandibular third molar who fulfill the inclusion criteria will be included in the study.
Informed consent will be obtained from the patient. 
After surgical removal of mandibular 3rd molar, CGF in gel form will be inserted into the socket in the study group. Absorbable gelatin sponge will be placed in the socket of the control group.
CGF will be prepared by collecting two 10 mL blood samples from the patient. The tubes will be centrifuged in centrifuge device immediately to prevent coagulation of blood. The guidelines of centrifugation to be followed are acceleration for 30 sec so as to reach 2700 rpm, rotated for 2 mins, then reduced to 2400 rpm, for 4 mins and then accelerated to 2700 rpm for 4 mins, then accelerated to 3000 rpm for 3 mins, and decelerated for 36 sec to stop.
3 layers that will be obtained in the tube are
1)Upper platelet poor plasma
2)Middle buffy coat containing CGF fibrin gel
3)Lower red blood cells
The middle buffy coat containing the CGF layer will be taken out of the tube and split from the red blood cells.
CGF fibrin gel will be then placed into the patient’s extraction socket and wound closure completed with silk suture.
Every patient will be recalled on day 4 day of surgery to evaluate healing progress. The onset of alveolar osteitis will be recorded based on the clinical appearance of the socket that will be quantified on a scoring system elaborated below.10 Sutures will be removed at day10 after surgery. Soft tissue healing will be evaluated.
 
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