Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions
Primary Purpose
Gingival Recession
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
connective tissue graft
platelet rich fibrin
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Recession focused on measuring multiple gingival recession, platelet rich fibrin, connective tissue graft, microsurgery, periodontal diseases, gingival recession
Eligibility Criteria
Inclusion Criteria:
- Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth
- Identifiable CEJ on all teeth
- Age ≥ 18
- Presence of tooth vitality and absence of restorations and superficial caries in the treatment area
- No past surgical treatment history of affected area.
- Gingival thickness ≥ 0,8 mm for recession areas.
- Sufficient palatal donor tissue for connective tissue harvesting.
Exclusion Criteria:
- Smoking
- Pregnancy or lactation
- Systematic diseases that may affect outcomes of periodontal therapy
- Self-reported antibiotic medication within three months
- Occlusal trauma in treatment site
Sites / Locations
- Ege University School of Dentistry Department of Periodontology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
connective tissue graft
Platelet rich fibrin
Arm Description
connective tissue graft harvested from palatum of subjects and placed under modified coronally advanced flap
Autogenous platelet rich fibrin was obtained from subjects own blood samples after centrifugation. Platelet rich fibrin membranes were placed under modified coronally advanced flaps.
Outcomes
Primary Outcome Measures
Mean root coverage percentage
mean area of root coverage achieved by surgical root coverage therapy.
complete root coverage percentage
percentage of gingival recession defects completely covered by flaps after 6 months
Secondary Outcome Measures
keratinized tissue width
changes in keratinized tissue width at 6 months
gingival tissue thickness
changes from baseline in gingival tissue thickness at 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02018120
Brief Title
Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions
Official Title
Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.
Detailed Description
The aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (PRF) and connective tissue grafts in the treatment of multiple gingival recessions.
Primary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. The secondary outcome variables include keratinized tissue and gingival thickness gain.
Sample size has been estimated as 13 in each treatment arm. All recessions are treated with modified coronally advanced flap. On test sites PRF membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. Random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization.
Clinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. Probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. All gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software.
Clinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures.
Gingival tissue thickness were measured with an #15 endodontic reamer attached to rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness of the reamer will be measured with a digital caliper.
Mean root coverage percentage was calculated as percentage of covered root surface area at 6 months.
Follow up of subjects was 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
multiple gingival recession, platelet rich fibrin, connective tissue graft, microsurgery, periodontal diseases, gingival recession
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
connective tissue graft
Arm Type
Active Comparator
Arm Description
connective tissue graft harvested from palatum of subjects and placed under modified coronally advanced flap
Arm Title
Platelet rich fibrin
Arm Type
Experimental
Arm Description
Autogenous platelet rich fibrin was obtained from subjects own blood samples after centrifugation. Platelet rich fibrin membranes were placed under modified coronally advanced flaps.
Intervention Type
Procedure
Intervention Name(s)
connective tissue graft
Intervention Type
Procedure
Intervention Name(s)
platelet rich fibrin
Primary Outcome Measure Information:
Title
Mean root coverage percentage
Description
mean area of root coverage achieved by surgical root coverage therapy.
Time Frame
6 months
Title
complete root coverage percentage
Description
percentage of gingival recession defects completely covered by flaps after 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
keratinized tissue width
Description
changes in keratinized tissue width at 6 months
Time Frame
6 months
Title
gingival tissue thickness
Description
changes from baseline in gingival tissue thickness at 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Two or more adjacent teeth with at least 2 mm Miller Class I gingival recessions at non-molar teeth
Identifiable CEJ on all teeth
Age ≥ 18
Presence of tooth vitality and absence of restorations and superficial caries in the treatment area
No past surgical treatment history of affected area.
Gingival thickness ≥ 0,8 mm for recession areas.
Sufficient palatal donor tissue for connective tissue harvesting.
Exclusion Criteria:
Smoking
Pregnancy or lactation
Systematic diseases that may affect outcomes of periodontal therapy
Self-reported antibiotic medication within three months
Occlusal trauma in treatment site
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gül Atilla, Professor
Organizational Affiliation
Ege University School of Dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Ege University School of Dentistry Department of Periodontology
City
Izmir
State/Province
Bornova
ZIP/Postal Code
35100
Country
Turkey
12. IPD Sharing Statement
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Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions
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