NCT04942821

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 23, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2017

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
Last Updated

June 29, 2021

Status Verified

March 1, 2019

Enrollment Period

2.8 years

First QC Date

June 7, 2021

Last Update Submit

June 19, 2021

Conditions

Keywords

Gingival recessionPlastic surgeryPlatelet rich fibrinConnective tissue graftCoronally advanced flap

Outcome Measures

Primary Outcomes (1)

  • Percentage of Root Coverage

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

    12 months

Secondary Outcomes (7)

  • Complete Root Coverage

    12 months

  • Change from Baseline Keratinized Tissue Width at 3 months

    3 months

  • Change from Baseline Keratinized Tissue Width at 6 months

    6 months

  • Change from Baseline Keratinized Tissue Width at 12 months

    12 months

  • Change from Baseline Gingival Thickness at 3 months

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Platelet rich fibrin and coronally advanced flap

EXPERIMENTAL

Coronally advanced flap and platelet rich fibrin were used in treatment arms.

Procedure: Platelet rich fibrin and coronally advanced flap

Connective tissue graft and coronally advanced flap

ACTIVE COMPARATOR

Coronally advanced flap and connective tissue graft were used in treatment arms.

Procedure: Connective tissue graft and coronally advanced flap

Interventions

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.

Platelet rich fibrin and coronally advanced flap

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.

Connective tissue graft and coronally advanced flap

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yavuz A, Gungormek HS, Kuru L, Dogan B. Treatment of multiple adjacent gingival recessions using leucocyte- and platelet-rich fibrin with coronally advanced flap: a 12-month split-mouth controlled randomized clinical trial. Clin Oral Investig. 2024 May 1;28(5):291. doi: 10.1007/s00784-024-05694-3.

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Hatice Selin Yıldırım, Dr.

    Marmara University, Faculty of Denistry, Department of Periodontology

    STUDY CHAIR
  • Başak Doğan, Prof. Dr.

    Marmara University, Faculty of Denistry, Department of Periodontology

    STUDY DIRECTOR
  • Atacan Yavuz, Dr.

    Marmara University, Faculty of Denistry, Department of Periodontology

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 29, 2021

Study Start

April 23, 2014

Primary Completion

February 24, 2017

Study Completion

February 24, 2017

Last Updated

June 29, 2021

Record last verified: 2019-03