Viewing Study NCT02397122



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Study NCT ID: NCT02397122
Status: COMPLETED
Last Update Posted: 2018-10-26
First Post: 2015-02-13

Brief Title: Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment
Sponsor: Kırıkkale University
Organization: Kırıkkale University

Study Overview

Official Title: The Adjunctive Effect of Platelet Rich Fibrin to Connective Tissue Graft in the Treatment of Buccal Recession Defects Results of a Randomized Parallel Group Controlled Trial
Status: COMPLETED
Status Verified Date: 2018-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The aim of the trial is to evaluate the effectiveness of coronally advanced flap CAFconnective tissue graftCTGplatelet-rich fibrinPRF combination in Miller I and II recession treatment by comparing with CAFCTG 40 patients were surgically treated either with CAFCTGPRF test group or CAFCTG 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
Detailed Description: Given the encouraging effects of platelet-rich fibrin PRF in healing and regeneration it has been hypothesized that PRF might develop the outcomes obtained with coronally advanced flap CAFconnective tissue graftCTG Therefore it was aimed to evaluate the effectiveness of CAF CTG PRF in Miller Class I and II recession defect treatment by comparing the outcomes with CAF CTG in a preliminary controlled randomized clinical trial RCT with a 6-month follow-up The study was conducted with 40 patients randomly grouped in half shares into indicated study groups After phase I therapy clinical variables including 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 The surgical sites were prepared by using sulcular and adjacent vertical incisions and CTGs were harvested from the palatal regions Different from CAFCTG group PRF was prepared by obtaining 10 ml venous blood centrifugation and extraction of the gel containing highly concentrated platelet cells in CAFCTGPRF patients Then the gel was placed over the exposed root surface in the same group The CAF was primarily closed and postoperative instructions were given After suture removal at second postoperative week the patients were followed-up by monthly recall visits Same periodontal clinical variables were recorded 3 and 6 months after surgery

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None