| CTRI Number |
CTRI/2025/06/089642 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two treatment modalities for increasing width of gum tissue around natural teeth |
|
Scientific Title of Study
|
Evaluating the efficacy of T-PRF
and FGG with MARF in keratinized tissue augmentation around
natural teeth 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 |
Jinita Desai |
| Designation |
Post Graduate Student |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Ground Floor Department of Periodontics and Implantology Manubhai Patel Dental College and Hospital vishwajyoti ashram near vidyakunj school muj mahuda vadodara gujarat
Ground Floor Department of Periodontics and Implantology Manubhai Patel Dental College and Hospital vishwajyoti ahsram near vidyakunj school muj mahuda vadodara gujarat
Vadodara
GUJARAT
390011
India |
| Phone |
9574756062 |
| Fax |
|
| Email |
drjinitadesai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivlal Vishnoi |
| Designation |
Professor and Head |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Ground Floor Department of Periodontics and Implantology Manubhai Patel Dental College and Hospital vishwajyoti ashram near vidyakunj school muj mahuda gujarat
Ground Floor Department of Periodontics and Implantology Manubhai Patel Dental College and Hospital vishwajyoti ashram near vidyakunj school muj mahuda gujarat
Vadodara
GUJARAT
390011
India |
| Phone |
9586869196 |
| Fax |
|
| Email |
vishnoi_shivlal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivlal Vishnoi |
| Designation |
Professor and Head |
| Affiliation |
Manubhai Patel Dental College and Hospital |
| Address |
Ground Floor Department of Periodontics and Implantology Manubhai Patel Dental College and Hospital vishwajyoti ashram near vidyakunj school muj mahuda gujarat
Ground Floor Department of Periodontics and Implantology Manubhai Patel Dental College and Hospital vishwajyoti ashram near vidyakunj school muj mahuda gujarat
Vadodara
GUJARAT
390011
India |
| Phone |
9586869196 |
| Fax |
|
| Email |
vishnoi_shivlal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Dr Jinita Desai
Department of periodontics and implantology
Manubhai Patel Dental College and Hospital vishwajyoti ashram near vishwamitri bridge muj mahuda
Vadodara
Gujarat
390011
india |
|
|
Primary Sponsor
|
| Name |
DrJinita Desai |
| Address |
Department of Periodontics and Implantology Manubhai Patel Dental College and Hospital Vishwajyoti ashram near vidyakunj school muj mahuda vadodara gujarat 390011 india |
| 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 |
| DrJinita Desai |
Manubhai Patel Dental College and Hospital |
Ground Floor Department of Periodontics and Implantology Manubhai Patel Dental College and Hospital
Vishwajyoti ashram near Vidyakunj school muj mahuda
Vadodara
GUJARAT |
9574756062
drjinitadesai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research of manubhai patel dental college and hospital and ORI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual without systemic disease |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FGG with MARF for keratinized tissue augmentation around natural teeth |
Keratinized tissue augmentation around natural teeth done using MARF technique with FGG at baseline,3 months and 6 months |
| Intervention |
T-PRF with MARF for keratinized tissue augmentation around natural teeth |
Keratinized tissue augmentation around natural teeth done using MARF technique with T-PRF at baseline,3 months and 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with less than 2mm of keratinized gingiva on buccal or vestibular side
Systemically healthy patients
age 18 to 55 years old
|
|
| ExclusionCriteria |
| Details |
Patients with a history of smoking or alcohol use
Patients with poor oral hygiene and those who are noncompliant
PPD more than 5mm
Patients who previously received radiation therapy of the jaws
Pregnant and lactating mothers
Previous history of PDL plastic surgery in same site within 6 months
|
|
|
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)Keratinized tissue width(KTW)
2)Gingival thickness(GT)
|
1)Keratinized tissue width(KTW) will be evaluated at baseline, 3 months and 6 months
2)Gingival thickness(GT) will be evaluated at baseline, 3 months and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual analogue score (VAS) |
Visual analogue score will be evaluated at 7th day after surgery |
| Time taken for surgical procedure |
The time taken for surgical procedure will be assessed from the horizontal incision given to the completion of suturing the graft material at the recipient area. |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
21/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
To compare T- PRF with MARF and free gingival graft with
MARF for keratinized tissue augmentation around natural teeth To examine soft tissue changes in the form of Keratinized tissue width and Gingival thickness after 3 month and 6 month follow up period |