The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin
Primary Purpose
Root Coverage
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Platelet rich fibrin and coronally advanced flap
Connective tissue graft and coronally advanced flap
Sponsored by
About this trial
This is an interventional treatment trial for Root Coverage focused on measuring Gingival recession, Plastic surgery, Platelet rich fibrin, Connective tissue graft, Coronally advanced flap
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Platelet rich fibrin and coronally advanced flap
Connective tissue graft and coronally advanced flap
Arm Description
Coronally advanced flap and platelet rich fibrin were used in treatment arms.
Coronally advanced flap and connective tissue graft were used in treatment arms.
Outcomes
Primary Outcome Measures
Percentage of Root Coverage
The percentage of root coverage was calculated according to the preoperative recession depth to postoperative recession depth.
Secondary Outcome Measures
Complete Root Coverage
Complete root coverage was calculated according to measurement of the pre and post operative gingival margin which was above the enamel-sement junction.
Change from Baseline Keratinized Tissue Width at 3 months
Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
Change from Baseline Keratinized Tissue Width at 6 months
Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
Change from Baseline Keratinized Tissue Width at 12 months
Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
Change from Baseline Gingival Thickness at 3 months
Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
Change from Baseline Gingival Thickness at 6 months
Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
Change from Baseline Gingival Thickness at 12 months
Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04942821
Brief Title
The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin
Official Title
Treatment of Multiple Adjacent Gingival Recessions With Coronally Advanced Flap in Combination With Platelet-Rich Fibrin: A Split-Mouth Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 23, 2014 (Actual)
Primary Completion Date
February 24, 2017 (Actual)
Study Completion Date
February 24, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Coverage
Keywords
Gingival recession, Plastic surgery, Platelet rich fibrin, Connective tissue graft, Coronally advanced flap
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet rich fibrin and coronally advanced flap
Arm Type
Experimental
Arm Description
Coronally advanced flap and platelet rich fibrin were used in treatment arms.
Arm Title
Connective tissue graft and coronally advanced flap
Arm Type
Active Comparator
Arm Description
Coronally advanced flap and connective tissue graft were used in treatment arms.
Intervention Type
Procedure
Intervention Name(s)
Platelet rich fibrin and coronally advanced flap
Intervention Description
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
Intervention Name(s)
Connective tissue graft and coronally advanced flap
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Root Coverage
Description
The percentage of root coverage was calculated according to the preoperative recession depth to postoperative recession depth.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Complete Root Coverage
Description
Complete root coverage was calculated according to measurement of the pre and post operative gingival margin which was above the enamel-sement junction.
Time Frame
12 months
Title
Change from Baseline Keratinized Tissue Width at 3 months
Description
Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
Time Frame
3 months
Title
Change from Baseline Keratinized Tissue Width at 6 months
Description
Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
Time Frame
6 months
Title
Change from Baseline Keratinized Tissue Width at 12 months
Description
Width of keratinized tissue at mid-buccal point measured from free gingival margin to mucogingival junction
Time Frame
12 months
Title
Change from Baseline Gingival Thickness at 3 months
Description
Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
Time Frame
3 months
Title
Change from Baseline Gingival Thickness at 6 months
Description
Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
Time Frame
6 months
Title
Change from Baseline Gingival Thickness at 12 months
Description
Gingival thickness at mid-buccal aspect measured at the center of keratinized tissue.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Selin Yıldırım, Dr.
Organizational Affiliation
Marmara University, Faculty of Denistry, Department of Periodontology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Başak Doğan, Prof. Dr.
Organizational Affiliation
Marmara University, Faculty of Denistry, Department of Periodontology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Atacan Yavuz, Dr.
Organizational Affiliation
Marmara University, Faculty of Denistry, Department of Periodontology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Evaluation Clinical Results of Coronally Advanced Flap With Platelet Rich Fibrin
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