| CTRI Number |
CTRI/2025/12/099324 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of concentrated growth factor in healing after lower wisdom tooth removal |
|
Scientific Title of Study
|
Evaluation of efficacy of concentrated growth factor in post-extraction
Mandibular 3rd molar socket healing |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Ashok Prasanna |
| Designation |
Associate Professer |
| Affiliation |
Sathyabama Institute of Science and Technology |
| Address |
Room no: 2
Department of Oral and Maxillofacial Surgery
Jeppiaar Nagar, Rajiv Gandhi Salai, Chennai - 600 119, Tamil Nadu, India
Chennai
TAMIL NADU
600119
India |
| Phone |
9962603063 |
| Fax |
|
| Email |
drashokomfs.dental@sathyabama.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Ashok Prasanna |
| Designation |
Associate Professer |
| Affiliation |
Sathyabama Institute of Science and Technology |
| Address |
Room no: 2
Department of Oral and Maxillofacial Surgery,
Jeppiaar Nagar, Rajiv Gandhi Salai, Chennai - 600 119, Tamil Nadu, India
Chennai
TAMIL NADU
600119
India |
| Phone |
9962603063 |
| Fax |
|
| Email |
drashokomfs.dental@sathyabama.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Ashok Prasanna |
| Designation |
Associate Professer |
| Affiliation |
Sathyabama Institute of Science and Technology |
| Address |
Jeppiaar Nagar, Rajiv Gandhi Salai, Chennai - 600 119, Tamil Nadu, India
TAMIL NADU
600119
India |
| Phone |
9962603063 |
| Fax |
|
| Email |
drashokomfs.dental@sathyabama.ac.in |
|
|
Source of Monetary or Material Support
|
| Room no: 2, Department of Oral and maxillofacial surgery,
Sathyabama dental college and hospital
Near Sathyabama Engineering College, Old Mahabalipuram Road, Semmancheri, Chennai-600119 |
|
|
Primary Sponsor
|
| Name |
Sathyabama Institute of Science and Technology |
| Address |
Jeppiaar Nagar, Rajiv Gandhi Salai, Chennai - 600 119, Tamil Nadu, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 R Ashok Prasanna |
Sathyabama Dental College and Hospital |
Department of Oral and Maxillofacial surgery
Near Sathyabama Engineering College, Old Mahabalipuram Road, Semmancheri,Chennai - 600119
Chennai
TAMIL NADU |
9962603063
drashokomfs.dental@sathyabama.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Biosafety and Ethical Committee Meeting |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA class 1, 2
18 – 40 years of age
Patients who need tooth removal
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Concentrated growth factor |
About 10 ml of venous blood will be drawn aseptically from each patient immediately before the
procedure and would be transferred to a sterile CGF tube without the addition of anticoagulant. The
tube will then placed in a dedicated CGF centrifuge and w be processed using the standard preset
program to include an acceleration phase of 30 seconds followed by sequential centrifugation
at 2700 rpm at 2 minutes, 2400 for 4 minutes, 2700 rpm for 4 minutes and 3000 rpm for 3
minutes and a deceleration phase for 36 seconds. This variable speed protocol results in the
formation of three distinct layers: an upper serum layer, a middle light yellow gelatinous
CGF clot and a lower red blood cell fraction.The CGF layer will be carefully isolated using
sterile instruments ensuring that adjacent layers are not disrupted and will be kept ready for
placement in the surgical site. |
| Comparator Agent |
Without concentrated growth factor |
after performing the procedure which includes extraction of mandibular third molar, the socket will be sutured without the placement of Concentrated growth factor in it. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients classified as American Society of Anesthesiologists physical status one and two.
Patients aged eighteen to forty years.
Patients requiring tooth removal. |
|
| ExclusionCriteria |
| Details |
Patients classified as American Society of Anesthesiologists physical status three and four.
Patients with severe periodontitis or periapical diseases.
Patients with systemic diseases.
Patients with any pathological conditions involving the mandible. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Soft tissue healing |
Immediate post operative, 3rd day post operative, 7th day postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mouth opening |
Immediate post operative, 3rd day postoperative, 7th day post operative |
| Pain |
Immediate post operative, 3rd day post operative, 7th day postoperative |
| Swelling |
Immediate post operative, 3rd day post operative, 7th day postoperative |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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)
|
07/01/2026 |
| 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="6"
Days="15" |
|
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
|
This prospective in-vivo study includes 22 patients requiring mandibular third-molar extraction. Participants will be randomly allocated into test (CGF) and control groups (n = 11 each). After standardized surgical extraction, CGF will be placed in the socket of the test group, while the control group receives no adjunct. Postoperative outcomes—pain, swelling, and mouth opening—will be assessed using validated clinical measures at immediate, 3rd, and 7th postoperative days. Soft-tissue healing will be evaluated using the Landry healing index. Independent t-test and Wilcoxon signed-rank test will be used for statistical analysis. |