Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment

NCT02397122 | Completed Results

• 1 other identifier: KirikkaleU
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the trial is to evaluate the effectiveness of coronally advanced flap (CAF)+connective tissue graft(CTG)+platelet-rich fibrin(PRF) combination in Miller I and II recession treatment by comparing with CAF+CTG. 40 patients were surgically treated either with CAF+CTG+PRF (test group) or CAF+CTG (control group). Clinical parameters of plaque index (PI), gingival index (GI), vertical recession (VR), probing depth (PD), attachment level (AL), keratinized tissue width (KTW), horizontal recession (HR), MGJ localization (L-MGJ), tissue thickness (TT) were recorded at baseline, 3 months (PS1) and 6 months (PS2) post-surgery. Root coverage (RC), complete RC (CRC), attachment gain (AG), and keratinized tissue change (KTC) were also calculated.

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

• Vertical Recession

  Measured from cementoenamel junction to margin of the gingiva by periodontal probe

  Baseline, 6 weeks and 6 months

Secondary Outcomes (5)

• Horizontal Recession

  Baseline, 6 weeks and 6 months

• Probing Depth

  Baseline, 6 weeks and 6 months

• Attachment Level

  Baseline, 6 weeks and 6 months

• Keratinized Tissue Width

  Baseline, 6 weeks and 6 months

• Tissue Thickness

  Baseline, 6 weeks and 6 months

Study Arms (2)

PRF+CAF+CTG

EXPERIMENTAL

platelet-rich fibrin + coronally advanced flap + connective tissue graft

Biological: platelet-rich fibrin; Procedure: connective tissue graft; Procedure: coronally advanced flap

CAF+CTG

ACTIVE COMPARATOR

coronally advanced flap + connective tissue graft

Procedure: connective tissue graft; Procedure: coronally advanced flap

Interventions

platelet-rich fibrin BIOLOGICAL

autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods

PRF+CAF+CTG

connective tissue graft PROCEDURE

connective tissue graft was harvested from the palatal region of each patient by single incision method

CAF+CTG; PRF+CAF+CTG

coronally advanced flap PROCEDURE

buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)

CAF+CTG; PRF+CAF+CTG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Systemically healthy
• Single Miller type I or II recession defect ≥ 3 mm localized to anterior/premolar area
• No alveolar bone loss
• Identifiable cemento-enamel junction
• Probing depth ≤3mm

You may not qualify if:

• Smoking
• Pregnancy
• History of periodontal surgery in last two years
• Mobility
• Excessive occlusal contacts
• Caries
• Loss of vitality

Sponsors & Collaborators

• Kırıkkale University: lead

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Results Point of Contact

• Title: Dr. H. Gencay Keceli
• Organization: Kirikkale University

monsieur_gencay@yahoo.com

+905326714377

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: March 24, 2015
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: October 26, 2018
• Results First Posted: May 1, 2018

Record last verified: 2018-09