PRF for Accelerating Palatal Healing

Gingival Recession Clinical Trial

Official title:

The Effects of Platelet-Rich Fibrin on Palatal Wound Healing After Free Gingival Graft Harvesting: A Comparative Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712242
• Other study ID #: CukurovaU8
• Status: Completed
• Phase: N/A
• First received: March 9, 2016
• Last updated: March 14, 2016
• Start date: November 2013
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Backgroung: Various agents are used to reduce post-operative complications associated with palatal donor site surgery for free gingival graft (FGG) harvesting. This study was conducted to evaluate the effects of platelet-rich fibrin (PRF) on palatal wound healing.

Description:

125 patients with isolated recessions were treated. The connective tissue graft was obtained by the de-epithelialization of a free gingival graft in both groups. Three different hemostatic treatments were randomized; PRF with cyanoacrilate adhesive (PRF group, n:42), cyanoacrilate adhesive alone (BC group, n:42) and sterile wet gauze compression (WG group, n:41). Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded for different time points.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 48 Years

Eligibility

Inclusion Criteria:

• no contraindications for periodontal surgery;

• full-mouth plaque score of <10%

• full-mouth bleeding score of <15%.

Exclusion Criteria:

• previously undergone surgery for a graft harvested from the palate

• presence of systemic disease or taking medication known to interfere with periodontal health

• smokers

• possible coagulation disorders

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Other:
• Platelet Rich Fibrin
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds.
• Butyl cyanoacrylate
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds.
• Wet gauze
Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epithelialization	Assessed according to the toluedine blue coloring	One month	No
Secondary	Sensibility disorders	visual analogue scale scores	One month	No
Secondary	feeding habits	visual analogue scale scores	One month	No
Secondary	Delayed bleeding	Bleeding assesment for post-operative one week	1 week	No
Secondary	Immediate Bleeding	Bleeding assesment for post-operative one hour	1 hour	No
Secondary	Pain	Visual Analague Scale scores	3 months	No