| CTRI Number |
CTRI/2020/02/023620 [Registered on: 27/02/2020] Trial Registered Prospectively |
| Last Modified On: |
27/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the healing of inner surface of the upper jaw after harvesting tissue with and without using a product of blood as a dressing material |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the healing of palatal donor site after harvesting free gingival graft with and without using platelet rich fibrin as a biological dressing |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMRUTH GANESH |
| Designation |
Post-Graduate student |
| Affiliation |
YENEPOYA DENTAL COLLEGE |
| Address |
Department of Periodontology,
Yenepoya Dental College,
Yenepoya deemed to-be University,
Deralakatte,
Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8903848945 |
| Fax |
|
| Email |
dr.amruthganesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHASHIKANTH HEGDE |
| Designation |
PROFESSOR and HEAD |
| Affiliation |
YENEPOYA DENTAL COLLEGE |
| Address |
Department of Periodontology,
Yenepoya Dental College,
Yenepoya deemed to-be University,
Deralakatte,
Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9343569220 |
| Fax |
|
| Email |
shashiperio@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
AMRUTH GANESH |
| Designation |
Post-Graduate student |
| Affiliation |
YENEPOYA DENTAL COLLEGE |
| Address |
Department of Periodontology,
Yenepoya Dental College,
Yenepoya deemed to-be University,
Deralakatte,
Mangalore-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8903848945 |
| Fax |
|
| Email |
dr.amruthganesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Amruth Ganesh (self),
Department of Periodontology,
Yenepoya Dental College,
Yenepoya Deemed to-be University,
Deralakatte,
Mangalore-575018. |
|
|
Primary Sponsor
|
| Name |
Amruth Ganesh |
| Address |
Department of Periodontology,
Yenepoya Dental College,
Yenepoya Deemed to-be University,
Deralakatte,
Mangalore-575018. |
| 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 AMRUTH GANESH |
YENEPOYA DENTAL COLLEGE |
DEPARTMENT OF PERIODONTOLOGY,
YENEPOYA DENTAL COLLEGE,
YENEPOYA DEEMED to-be UNIVERSITY,
DERELAKATTE,
MANGALORE-575018
Dakshina Kannada
KARNATAKA |
8903848945
dr.amruthganesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Centre 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with Gingival recession and indicated for Free Gingival graft surgical procedure. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Platelet-Rich Fibrin(PRF) used as a biological dressing |
after harvesting free gingival graft from the palatal donor site, the healing of the donor site occurs through secondary intention. The morbidity experienced by the patient in the donor site is the major concern of the free gingival graft procedure. in order to hasten the healing process of the palatal donor site, PRF is used as a biological dressing at the palatal donor site. the PRF membrane being rich in growth factors help in faster epithelialisation of the donor site, thereby reducing the time taken for healing and reducing the patient pain and discomfort. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
-Subjects indicated for free gingival graft procedure.
-Subjects willing to give informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
-Subjects suffering from any debilitating condition.
-Immuno-compromised subjects.
-Pregnant women
-Lactating mothers
-Subjects with habits like alcoholism, smoking, chewing tobacco.
-Subjects under Anti-coagulant medication. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the enhanced wound healing of the palatal donor site with and without using PRF as a biological dressing. |
the patient is assessed at 10th, 20th, and 30th days post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient comfort/discomfort is assessed using VAS score |
the patient is assessed at 10th, 20th, and 30th days post operatively. |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/03/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
at the end of the study, all findings and results of the study will be submitted for publication in an indexed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The root coverage procedures are performed for the correction of gingival recession, which is necessary for aesthetic demands, root hypersensitivity, root carious lesions, and cervical abrasions. One of the treatment modalities performed for the gingival recession is free gingival graft(FGG). The keratinized gingiva of the hard palate is one of the common sites for obtaining a free soft tissue graft for periodontal plastic surgical procedure. They yield excellent clinical results and are considered superior. The disadvantages of free gingival grafts are requirement of second surgical site, tissue necrosis, hemorrhage, discomfort and pain. the donor site healing occurs by secondary intention and it takes about 2-4 weeks for the healing to be complete. There is very minimal literature evidence to overcome the disadvantages of the free gingival graft procedure. Choukroun’s platelet rich fibrin is a second generation platelet concentrate that is used in wound healing of skin wounds and recent evidences suggest application of PRF for various modalities in the periodontal therapy. The PRF has stimulatory effect on wound healing due to the presence of various growth factors and also acts as an excellent scaffold for angiogenesis and epithelialisation. This study is time bound (18 Months) randomized controlled clinical trial, patients fulfilling the inclusion and exclusion criteria during the study period will be recruited for the study. This study is aimed to evaluate the palatal wound healing after free gingival graft procedure by comparing the healing parameters, cytological study and VAS score of the recruited subjects whose palatal wounds are to dressed with PRF as a biological dressing with those whose wounds are not to be treated with a biological dressing. |