PRF for Treating Maxillary Gingival Recession

Gingival Recession Clinical Trial

Official title:

PRF for Treating Maxillary Gingival Recessions: A Split-mouth, Randomized, Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05267015
• Other study ID #: ArabAmericanU
• Status: Completed
• Phase: N/A
• Start date: January 3, 2021
• Est. completion date: November 14, 2021

Study information

• Verified date: February 2022
• Source: Arab American University (Palestine)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a split-mouth, randomized, controlled clinical trial that aims to evaluate the clinical efficacy of platelet-rich fibrin (PRF) membranes in conjunction with coronally advanced flap (CAF) in treating maxillary gingival recession defects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 14, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Greater than 18 years old
• Bilateral Miller class I + II recession in the upper jaw

Exclusion Criteria:

• Smokers
• Patients with systemic diseases that could interfere with the healing
• Patients undergoing bisphosphonate therap .Patients who previously received radiation therapy of the jaws.

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Gingival coverage using coronally advanced flap and a connective tissue graft
A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using a subepithelial connective tissue graft
• Gingival coverage using coronally advanced flap and platelet rich fibrin membranes
A coronally advanced flap is applied for recession coverage in the maxilla in a split-mouth randomized trial using platelet rich fibrin membranes

Locations

Country	Name	City	State
Palestinian Territory, occupied	Arab American University	Ramallah

Sponsors (1)

Lead Sponsor	Collaborator
Arab American University (Palestine)

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in gingival height (recession coverage)	The measurements of the increase in gingival height (recession coverage) using a linear evaluation (corono-apical direction) with a periodontal probe (Merrit-B; Hu-Friedy, Chicago, IL, USA) at the interventions sites to the nearest 0.5 mm. Registration of the recession height was done before treatment and after 6 weeks.	six weeks
Primary	Shrinkage in gingival height	To assess the shrinkage of the gingival height, the amount of gingival height vestibular to the treated teeth in a corono-apical direction was measured after the surgery and after six months.	six months
Secondary	Postoperative pain visual analog scores (VAS) and surgery time	This questionnaire used 100 mm visual analog scores VAS to evaluate the amount of pain, ranging from 0 (no pain) to 10 (worst pain imaginable), and the amount of swelling. Patients were asked to fill in the VAS scales at day 7 and day 14 at suture removal. The time of surgery was measured of both treatment options. Timing started at the moment of first incision until the last suture.	two weeks