CTRI Number |
CTRI/2023/05/053103 [Registered on: 24/05/2023] Trial Registered Prospectively |
Last Modified On: |
24/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Effect of blood processed bandage on wound healing in mouth |
Scientific Title of Study
|
Effect Of T-PRF Bandage on Pain and Epithelial Wound Healing at Palatal Donor Site: An Examiner-Masked, Randomized, Controlled Clinical Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Satyaki Verma |
Designation |
PG Student |
Affiliation |
Institute Of Dental Sciences |
Address |
Room no 228, Department of Periodontology and Implantology
Bareilly UTTAR PRADESH 244001 India |
Phone |
09897517095 |
Fax |
|
Email |
satyakiverma@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Rika Singh |
Designation |
Reader |
Affiliation |
Institute Of Dental Sciences |
Address |
Department of Periodontology and implantology, Institute Of Dental Sciences, Bareilly
Bareilly UTTAR PRADESH 243006 India |
Phone |
9458411133 |
Fax |
|
Email |
rikasingh22@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Satyaki Verma |
Designation |
PG Student |
Affiliation |
Institute Of Dental Sciences |
Address |
Room no 228, Department of Periodontology and Implantology
Bareilly UTTAR PRADESH 244001 India |
Phone |
09897517095 |
Fax |
|
Email |
satyakiverma@gmail.com |
|
Source of Monetary or Material Support
|
Institute of Dental Sciences, Bareilly |
|
Primary Sponsor
|
Name |
Satyaki Verma |
Address |
Room no 224, Department of Periodontology and Implantology, Institute of Dental Sciences, Bareilly |
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 |
Satyaki Verma |
Institute of Dental Sciences |
Room no 224, Department of Periodontology and Implantology Bareilly UTTAR PRADESH |
09897517095
satyakiverma@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
lyophilized hydrolyzed collagen sponge |
Placement of the lyophilized hydrolyzed collagen sponge over the palatal exposed site resulting from the extraction of Free Gingival Graft and healing that occurs after 21 days |
Intervention |
Titanium prepared Platelet Rich Fibrin(TPRF) |
Placement of the Titanium prepared Platelet Rich Fibrin(TPRF) over the palatal exposed site resulting from the extraction of Free Gingival Graft and healing that occurs after 21 days. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Age more than 18 years.
Without systemic diseases,
No medical contraindications for periodontal surgery, and
Adequate level of plaque control (plaque index < 15%).
|
|
ExclusionCriteria |
Details |
Systemically compromised patients e.g.-uncontrolled diabetes
Patients who are on medications that could interfere with wound healing.
Patients having to use removable partial denture for the upper arch.
Pregnant and lactating females.
Evidence of Malocclusion, or Crowding or any other local factors complicating the overall prognosis of the area.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
The aim of this randomized controlled clinical trial is to assess the effect of Titanium prepared, platelet-rich fibrin (T-PRF) membranes on healing and re-epithelization of palatal wounds resulting from free gingival graft (FGG) harvesting. |
Baseline,2 Months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess the level of wound healing and epithelization by the use of TPRF on FGG extracted site during wound healing post-surgery in the test group.
To assess the level of wound healing and epithelization on the FGG extracted site during wound healing post-surgery in the control group.
To find out any possible difference between the two and the extent to which the TPRF influences the wound healing, epithelization and patient related outcomes.
|
Baseline,2 Months |
|
Target Sample Size
|
Total Sample Size="6" Sample Size from India="6"
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 2 |
Date of First Enrollment (India)
|
08/06/2023 |
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="2" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Free
gingival graft (FGG) is a successful treatment for deficiency of keratinized
soft tissue surrounding teeth and implants. In the conventional FGG procedure,
the keratinized gingiva consisting of epithelium and a thin layer of underlying
connective tissue from the donor site is transferred to the recipient site. It
is suggested that 2 mm of keratinized tissue is adequate to maintain gingival
and peri-implanter health. The keratinized gingiva surrounding the teeth and
implants increases the resistance of the tissues to shrinkage and provides
stability during prosthetic procedures. In cases where there is insufficient attached
gingiva/peri-implant keratinized mucosa, it is necessary to increase the amount
of attached soft tissue by using mucogingival surgical methods such as FGG
procedures.7-11
A
platelet-rich fibrin clot (PRF) is preferred for the stabilization and
revascularization of hard and soft tissue grafts due to their growth factors
and plays a decisive role in haemostasis with its coagulating factors. From the
moment it is applied to the area, it turns into a kind of biological adhesive
shield that can consolidate the first set of platelets, thereby creating a
vascularized protective wall to decrease the risk of contamination by
microorganisms. The acceleration of vascularization due to growth factors, absence
of toxic or allergic reactions due to autogenous graft, being economical and
biocompatible are some of the advantages of applying PRF to the donor site. In
recent years, titanium-prepared PRF (T-PRF) which is based on the hypothesis
that titanium tubes may be more effective activating platelets than the glass
tubes are used as an alternative for PRF. It has been stated that the contact of
PRF and the silica is inevitable due to the preparation in a glass tube which
makes the affiliation weaker in conventional PRF. Besides, the activation of
platelets with titanium compared with activation with silica particles might
provide increased biocompatibility due to possible adverse effects of silica
particles. Several studies revealed that T-PRF has a longer resorption time
than conventional PRF.12
Therefore,
this study aimed to assess the healing effect of T-PRF clot membranes in
palatal wounds after FGG harvesting and to compare the postsurgical pain
experience and complications with a conventional procedure where a gelatine
sponge was placed in the palatal wound. |