| CTRI Number |
CTRI/2025/06/089697 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [USING BLOOD PRODUCTS TO ENHANCE HEALING AFTER WISDOM TOOTH SURGERY] |
| Study Design |
Other |
|
Public Title of Study
|
A study on how using a blood product helps in faster healing after removing lower wisdom teeth |
|
Scientific Title of Study
|
Influence of concentrated growth factor CGF on short term clinical outcomes following the surgical removal of partially erupted mandibular third molars a prospective clinical 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 |
Dr Chaitya Adalja |
| Designation |
Post graduate student in department of oral and maxillofacial surgery |
| Affiliation |
KM Shah Dental Collage and Hospital Waghodia Vadodara- 391760 |
| Address |
2 Department Of Oral And Maxillofacial Surgery KM Shah Dental Collage and Hospital Sumandeep Vidyapeeth Pipariya Waghodia 391760
Vadodara GUJARAT 391760 India |
| Phone |
9687216320 |
| Fax |
|
| Email |
adaljachaitya@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amit Mahajan |
| Designation |
Professor Department of Oral and Maxillofacial Surgery |
| Affiliation |
KM Shah Dental Collage and Hospital Sumandeep Vidyapeeth Pipariya Waghodia 391760 |
| Address |
2 Department of Oral and Maxillofacial Surgery KM Shah Dental Collage and Hospital Sumandeep Vidyapeeth Pipariya Waghodia
Vadodara GUJARAT 391760 India |
| Phone |
9924264787 |
| Fax |
|
| Email |
dramitmds@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr chaitya adalja |
| Designation |
Post graduate student in department of oral and maxillofacial surgery |
| Affiliation |
Km shah dental collage and hospital waghodia vadodara- 391760 |
| Address |
2 Department of oral and maxillofacial surgery km shah dental collage and hospital sumandeep vidyapeeth pipariya waghodia
Vadodara GUJARAT 391760 India |
| Phone |
9687216320 |
| Fax |
|
| Email |
adaljachaitya@gmail.com |
|
|
Source of Monetary or Material Support
|
| KM Shah dental collage and Hospital sumandeep vidyapeeth Pipariya Waghodia vadodara gujrat 391760 |
|
|
Primary Sponsor
|
| Name |
Dr Chaitya Adalja |
| Address |
2 Department of Oral and Maxillofacial Surgery KM Shah Dental Collage and Hospital Sumandeep Vidyapeeth Pipariya Waghodia vododara gujrat india 391760 |
| 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 chaitya adalja |
Km shah dental college and hospital sumandeep vidyapeeth vadodara gujrat |
Room number 2 department of oral and maxillofacial surgery km shah dental college and hospital sumandeep vidyapeeth pipariya waghodia vadodara gujrat india 391760 Vadodara GUJARAT |
9687216320
adaljachaitya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeep vidyapeeth institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Concentrated growth factor |
Concentrated growth factor (CGF), a third-generation platelet concentrate which is helpful for healing process. This CGF will be placed in the socket after mandibular 3rd molar surgery. Then healing will be assessed at 3rd and 7th day postoperatively and study will be done for 14 patients within 6 months |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having partially erupted mandibular 3rd molar
2 Patients american society of anaesthesiologist
classification will be I or II |
|
| ExclusionCriteria |
| Details |
1 Patients not willing to participate in study
2 Patients with uncontrolled comorbidity and medically compromised
3 Patients diagnosed with coagulopathy
4 Patients with comorbid periodontitis gingivitis or oral infectious disease
5 Patients using hormone therapy in the last 6 month
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will help us to conclude effectiveness of using concentrated growth factor in 3rd molar surgery |
This study will help us to conclude effectiveness of using concentrated growth factor in 3rd molar surgery at 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="14" Sample Size from India="14"
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)
|
10/07/2025 |
| 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="0" 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
|
Surgical extraction of third molar teeth is one of the most frequently performed procedures in oral surgery practice. Surgical extraction of third molars often results in pain, swelling, and trismus. While platelet concentrates like PRP and PRF have shown benefits in healing, limited research exists on concentrated growth factor (CGF), especially for partially erupted third molars. Concentrated growth factor (CGF), a third-generation platelet concentrate, has many advantages compared with first- and second-generation platelet concentrates, i.e., platelet-rich plasma (PRP) and platelet-rich fibrin (PRF). CGF is a new biomaterial discovered after platelet-rich plasma (PRP) and platelet rich fibrin (PRF), which contains a variety of high concentration growth factors and fibrin. As a concentrate from autologous blood, CGF can avoid the risk of immune rejection and can be safer and more economical than other fillers. This study aims to evaluate CGF’s effectiveness in reducing postoperative pain, swelling, and enhancing wound healing in 3rd molar surgeries. |