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

NCT ID: NCT04942821

Last Updated: 2021-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-23
• Study Completion Date: 2017-02-24

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.

Detailed Description

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.

Conditions

Root Coverage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Platelet rich fibrin and coronally advanced flap

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

Group Type: EXPERIMENTAL

Platelet rich fibrin and coronally advanced flap

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Connective tissue graft and coronally advanced flap

Intervention Type: 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.

Interventions

Platelet rich fibrin and coronally advanced flap

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.

Intervention Type: PROCEDURE

Connective tissue graft 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hatice Selin Yıldırım, Dr.

Role: STUDY_CHAIR

Marmara University, Faculty of Denistry, Department of Periodontology

Başak Doğan, Prof. Dr.

Role: STUDY_DIRECTOR

Marmara University, Faculty of Denistry, Department of Periodontology

Atacan Yavuz, Dr.

Role: PRINCIPAL_INVESTIGATOR

Marmara University, Faculty of Denistry, Department of Periodontology

References

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.

Reference Type: DERIVED

PMID: 38691209 (View on PubMed)

Other Identifiers

22-04-2014/418

Identifier Type: -

Identifier Source: org_study_id