| CTRI Number |
CTRI/2024/07/070109 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing healing of palatal wound with two different materials |
|
Scientific Title of Study
|
Clinical Comparison of Platelet Rich Fibrin and Collagen Dressing in the Management of Palatal Wounds:A Randomized Controlled Clinical Trial. |
| 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 Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department of Periodontology,room no 4,Sinhgad Dental College and Hospital,Vadgaon Budruk,Off Sinhgad Road,Pune-411041
Pune
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department of Periodontology,room no 4,Sinhgad Dental College and Hospital,Vadgaon Budruk,Off Sinhgad Road,Pune-411041
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nihal Devkar |
| Designation |
Professor |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department of Periodontology,room no 4,Sinhgad Dental College and Hospital,Vadgaon Budruk,Off Sinhgad Road,Pune-411041
Pune
MAHARASHTRA
411041
India |
| Phone |
9420481441 |
| Fax |
|
| Email |
drdevkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sinhgad Dental College and Hospital, S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune,
Maharashtra 411041, India |
|
|
Primary Sponsor
|
| Name |
Dr Simran C Jaisinghani |
| Address |
Sinhgad Dental College and Hospital,Dept no 4,-2 floor S.No 44/1,Vadgaon Bk,Off,,Sinhgad Rd,Pune,Maharashtra-411041 |
| 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 Simran C Jaisinghani |
Sinhgad Dental College and Hospital |
Department of
periodontology, room
no. 4, Sinhgad Dental
College and Hospital, S
No 44 1, Vadgaon
Budruk, 0ff, Sinhgad
Rd, Pune, Maharashtra
Pune MAHARASHTRA
Pune
MAHARASHTRA |
7030177979
simran.jaisinghani97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sinhgad Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
collagen dressing |
effect of collagen in healing of palatal wound after soft tissue grating procedures |
| Comparator Agent |
paltelet rich fibrin |
effect of platelet rich fibrin in healing of palatal wound after soft tissue grafting procedures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients requiring soft tissue grafts( Free gingival graft or de-epithlialised gingival graft) for gingival recession,inadequate keratinized tissue.
2) age between 18-60 years
3) systemic factors (no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation)
4) behavioural factors (no smoking habit)
5) patients willing to participate in the study and willing to sign the informed consent.
6) dental and periodontal factors (a full-mouth plaque score [FMPS] and a full-mouth bleeding score [FMBS] lower than 20% at the time of surgery. |
|
| ExclusionCriteria |
| Details |
Systemic disorders (immunologic diseases, uncontrolled diabetes mellitus, ongoing chemotherapy or radiotherapy)
2) Pregnancy or lactation
3) any uncontrolled systemic disease that might contraindicate periodontal surgery
4) Inability or unwillingness to provide informed consent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess epithelialization of wound |
1 week,2 weeks and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient morbidity measures(pain,discomfort and bleeding),healing of palatal wounds |
1 week,2 week |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The hard palate is a common source of soft-tissue grafts (STG) for periodontal and perio-plastic surgery procedures.The main drawbacks of such techniques are the two surgical sites,pain and discomfort experienced by the patient, especially at the donor sites and potential for postoperative bleeding from the donor area which heals by secondary intention resulting in longer healing time and discomfort in the first 2 postoperative weeks.Palatal donor site healing occurs through fibroblast proliferation, collagen synthesis, angiogenesis, and contraction of the wound. In addition, revascularization, immunity, and epithelial cell proliferation are crucial factors for optimal wound healing.In an endeavor to accelerate the healing process and to reduce prolonged bleeding and pain caused by the palatal wound, materials such as hemostatic agents (e.g., absorbable synthetic collagen, absorbable gelatin sponge, cyanoacrylate, oxidized regenerated cellulose, ferric sub sulfate)and more recently platelet concentrate have been used.Collagen dressings have extensively been used in dentistry due to its ability to achieve hemostasis, being chemotactic to fibroblasts and platelets and inducing mesenchymal proliferation and differentiation.These dressing control bleeding and stabilize blood clots as well as protect the wound bed while accelerating the healing process. Platelet-rich fibrin (PRF) is an immune and platelet concentrate collecting on a single fibrin membrane all the constituents of a blood sample favorable to healing and immunity.It has a rich source of growth factors and its application has been reported as an effective way to induce tissue response and regeneration. There are at least 60 different biologically active substances present in platelets which are involved in tissue repair mechanisms such as chemotaxis, cell proliferation and differentiation, angiogenesis, intracellular matrix deposition,immune modulation, antimicrobial activity, and remodeling. Platelet concentrates used in palatal wound healing have growth factors, such as fibroblast growth factor-basic (FGFb),vascular endothelial growth factor (VEGF), and angiopoietin and platelet-derived growth factor (PDGF) which are the main angiogenesis soluble factor. This could facilitate faster healing by exerting a positive influence on the mitogenesis of wound healing cells, angiogenesis, and promotion of cellular differentiation at the wound site.Platelet-rich fibrin supports the three main keys of wound healing mechanism that is “angiogenesis,†“immunity,†and “epithelial proliferation†and thus has implicated its use to protect open wounds and accelerate healing |