Skip to main content
OpenTrials
Completed

NCT Number: NCT04942821

The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin

The aim of this study was to evaluate the clinical outcomes of platelet- rich fibrin and coronally advanced flap technique in the treatment of multiple gingival recessions in comparison with connective tissue graft technique.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Root Coverage Gingival Diseases Gingival Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Aim of this study was to evaluate the clinical outcomes of platelet rich fibrin (PRF)+coronally advanced flap (CAF) technique in the treatment of multiple gingival recessions in comparison with connective tissue graft (CTG)+CAF technique.12 patients with bilateral Miller Class I multiple gingival recessions were treated with PRF+CAF (test group) and CTG+CAF (control group) technique in a split-mouth study design. Probing depth, recession depth (RD), clinical attachment level (CAL), recession width, position of gingival margin, papilla width, keratinized tissue height (KTH), keratinized tissue thickness (KTT) were measured at baseline and 3, 6 and 12 months after surgery. Root coverage (RC) and complete root coverage (CRC) ratios were evaluated post-operatively.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients had at two quadrants, adjacent Miller Class I and at least 2 mm or deeper recessions
  • Full mouth plaque score 20% and Full mouth bleeding on probing 10%
  • no active periodontal disease,
  • involving incisors, canines and premolars,
  • age ≥ 18 years

Exclusion criteria

  • Patients with general diseases which could affect healing process,
  • smokers
  • Patients had undergone periodontal surgery during the pervious 24 months on the involved sites,
  • pregnant or breastfeeding women
  • endodontic lesions or non-detectable cemento-enamel junctions at experimental teeth

Treatment and study plan

Platelet rich fibrin and coronally advanced flap

Procedure

CAF were used in treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. Two 10 cc tubes with clot activator were used to collect blood from the patient; blood was centrifuged at 2700 rpm for 12 min. PRF box was used to form fibrin clots into membranes. PRF was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.

Connective tissue graft and coronally advanced flap

Procedure

Control sites were treated by coronally advanced flap (CAF) combined with connective tissue graft (CTG). CAF were used in both treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. CTG was obtained with single incision method. CTG was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.

Primary outcomes

  1. Percentage of Root Coverage

    Time frame: 12 months

    The percentage of root coverage was calculated according to the preoperative recession depth to postoperative recession depth.

Secondary outcomes

  1. Complete Root Coverage

    Time frame: 12 months

    Complete root coverage was calculated according to measurement of the pre and post operative gingival margin which was above the enamel-sement junction.

  2. Change from Baseline Keratinized Tissue Width at 3 months

    Time frame: 3 months

    Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction

  3. Change from Baseline Keratinized Tissue Width at 6 months

    Time frame: 6 months

    Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction

  4. Change from Baseline Keratinized Tissue Width at 12 months

    Time frame: 12 months

    Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction

  5. Change from Baseline Gingival Thickness at 3 months

    Time frame: 3 months

    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.

  6. Change from Baseline Gingival Thickness at 6 months

    Time frame: 6 months

    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.

  7. Change from Baseline Gingival Thickness at 12 months

    Time frame: 12 months

    Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap in Combination With Platelet-Rich Fibrin: A Split-Mouth Study

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2021
Registry last updated
Jun 29, 2021

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.