Skip to main content
OpenTrials
Completed

NCT Number: NCT02397122

Platelet-rich Fibrin and Connective Tissue Graft in Recession Treatment

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gingival Recession Gingival Diseases Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 (CAF)+connective tissue graft(CTG). 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 CAF+CTG group, PRF was prepared by obtaining 10 ml venous blood, centrifugation and extraction of the gel containing highly concentrated platelet cells in CAF+CTG+PRF 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

platelet-rich fibrin

Biological

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

connective tissue graft

Procedure

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

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)

Primary outcomes

  1. Vertical Recession

    Time frame: Baseline, 6 weeks and 6 months

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

Secondary outcomes

  1. Horizontal Recession

    Time frame: Baseline, 6 weeks and 6 months

    measured horizontally between two borders of the recession at the line tangential to cementoenamel junction by periodontal probe

  2. Probing Depth

    Time frame: Baseline, 6 weeks and 6 months

    measured from margin of the gingiva to gingival sulcus base by periodontal probe

  3. Attachment Level

    Time frame: Baseline, 6 weeks and 6 months

    measured from cementoenamel junction to gingival sulcus base by periodontal probe

  4. Keratinized Tissue Width

    Time frame: Baseline, 6 weeks and 6 months

    measured from margin of the gingiva to mucogingival junction by periodontal probe

  5. Tissue Thickness

    Time frame: Baseline, 6 weeks and 6 months

    under local anesthesia, measured from 1.5 mm below the margin of the gingiva with a spreader and its stopper silicon disc. Then, distance of the marked point was measured by using a standardized caliper to the closest 0.1 mm by periodontal probe

Sponsors and collaborators

Lead sponsor

Kırıkkale University

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 24, 2015
Registry last updated
Oct 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.