The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin
June 19, 2021 updated by: Marmara University
Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap in Combination With Platelet-Rich Fibrin: A Split-Mouth Study
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Platelet rich fibrin and coronally advanced flap
Coronally advanced flap and platelet rich fibrin were used in treatment arms.
|
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.
|
|
Active Comparator: Connective tissue graft and coronally advanced flap
Coronally advanced flap and connective tissue graft were used in treatment arms.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 months
|
|
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 months
|
|
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
|
6 months
|
|
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
|
12 months
|
|
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.
|
3 months
|
|
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.
|
6 months
|
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 23, 2014
Primary Completion (Actual)
February 24, 2017
Study Completion (Actual)
February 24, 2017
Study Registration Dates
First Submitted
June 7, 2021
First Submitted That Met QC Criteria
June 19, 2021
First Posted (Actual)
June 29, 2021
Study Record Updates
Last Update Posted (Actual)
June 29, 2021
Last Update Submitted That Met QC Criteria
June 19, 2021
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-04-2014/418
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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