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

Phase 1

Recruiting

Conditions: Subjects with Gingival recession and indicated for Free Gingival graft surgical procedure.

Registration Number: CTRI/2020/02/023620

Lead Sponsor: Amruth Ganesh

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 14

Inclusion Criteria

Subjects indicated for free gingival graft procedure.
Subjects willing to give informed consent to participate in the study.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Patient comfort/discomfort is assessed using VAS score	the patient is assessed at 10th, 20th, and 30th days post operatively.

Trial Locations

Locations (1): YENEPOYA DENTAL COLLEGE
🇮🇳
Kannada, KARNATAKA, India
YENEPOYA DENTAL COLLEGE
🇮🇳Kannada, KARNATAKA, India
Dr AMRUTH GANESH
Principal investigator
8903848945
dr.amruthganesh@gmail.com