The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin
Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap in Combination With Platelet-Rich Fibrin: A Split-Mouth Study
1 other identifier
interventional
12
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 24, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 24, 2017
CompletedFirst Submitted
Initial submission to the registry
June 7, 2021
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedJune 29, 2021
March 1, 2019
2.8 years
June 7, 2021
June 19, 2021
Conditions
Keywords
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
EXPERIMENTALCoronally advanced flap and platelet rich fibrin were used in treatment arms.
Connective tissue graft and coronally advanced flap
ACTIVE COMPARATORCoronally advanced flap and connective tissue graft were used in treatment arms.
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.
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.
Eligibility Criteria
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.
PMID: 38691209DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hatice Selin Yıldırım, Dr.
Marmara University, Faculty of Denistry, Department of Periodontology
- STUDY DIRECTOR
Başak Doğan, Prof. Dr.
Marmara University, Faculty of Denistry, Department of Periodontology
- PRINCIPAL INVESTIGATOR
Atacan Yavuz, Dr.
Marmara University, Faculty of Denistry, Department of Periodontology
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