| 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
|
|
|
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
|
|
|
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. |