Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession

Titanium-prepared Platelet Rich Fibrin Versus Connective Tissue Graft for Management of Type-2 Gingival Recession: a Randomized Controlled Clinical Trial

The aim of the study is to evaluate the effectiveness of using titanium prepared platelet rich fibrin with coronally advanced flap in the treatment of type-2 Cairo gingival recession.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Other: T-PRF with CAF; Other: SECTG with CAF

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Gingival recession type 2 according to Cairo et al (2011).
• Adequate amount of Attached Gingiva (AG) (2 mm≤ AG).
• Good oral hygiene (full mouth bleeding score and O'Leary index less than ≤10 % after complete phase I therapy)
• Clinically thick gingival biotype (1mm < gingival thickness).
• Anterior esthetic zone.

Exclusion Criteria:

• Patients with gingival recession types 1 and 3 according to Cairo et al.
• Inadequate amount of attached gingiva (AG < 2 mm).
• Uncooperative patients.
• Smoking more than 10 cigarettes per day.
• Patients with known systemic conditions or taking medications that may affect soft tissue healing.
• Pregnant and lactating women.
• Patients with parafunctional habits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coronally advanced flap (CAF) in conjunction with titanium prepared PRF	Other: T-PRF with CAF; Blood sample will be obtained from the patient, conveyed into a titanium tube and immediately centrifuged at 2700 rpm for 12 mins at room temperature using fixed angle centrifuge (PRF Process, Tangkula800-1, China). The fibrin clot will be collected and placed in the PRF compression device (PRF GRF box) and condensed to produce a uniform T-PRF membrane which will be inserted over the recession area and covered by the coronally advanced flap.
Active Comparator: CAF in conjunction with subepithelial connective tissue graft (SECTG)	Other: SECTG with CAF; Sub epithelial connective tissue graft will be obtained from the donor site (hard palate), placed into recipient site and secured by sutures, then covered by a coronally advanced flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing depth	The distance from the base of the pocket to the most apical point on the gingival margin will be measured using a periodontal probe.	up to 6 months
Clinical attachment loss	Distance from the cement-enamel junction to the base of the periodontal pocket will be measured using a periodontal probe	up to 6 months
Recession width (RW)	Recession width (W) measured at the widest point (it is the distance between the mesial gingival margin and the distal gingival margin of the tooth) using a periodontal probe	up to 6 months
Recession height (RH)	It will be measured from the cementoenamel junction to the Gingival Margin (GM), parallel to the long axis of the tooth starting from the most apical point of the recession using a William's graduated periodontal probe	up to 6 months
Width of keratinized gingiva (KT)	Width of keratinized gingiva will be measured as the distance from the gingival margin to the mucogingival junction	up to 6 months

Collaborators and Investigators

• Sponsor: Rizk Beshir

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: September 28, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 28, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: 1/1-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No