- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02018120
Platelet Rich Fibrin in the Treatment of Multiple Gingival Recessions
Comparison of Platelet Rich Fibrin and Connective Tissue Graft in Treatment of Multiple Gingival Recessions
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bornova
-
Izmir, Bornova, Turkey, 35100
- Ege University School of Dentistry Department of Periodontology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
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 |
|---|---|
|
Active Comparator: connective tissue graft
connective tissue graft harvested from palatum of subjects and placed under modified coronally advanced flap
|
|
|
Experimental: Platelet rich fibrin
Autogenous platelet rich fibrin was obtained from subjects own blood samples after centrifugation.
Platelet rich fibrin membranes were placed under modified coronally advanced flaps.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean root coverage percentage
Time Frame: 6 months
|
mean area of root coverage achieved by surgical root coverage therapy.
|
6 months
|
|
complete root coverage percentage
Time Frame: 6 months
|
percentage of gingival recession defects completely covered by flaps after 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
keratinized tissue width
Time Frame: 6 months
|
changes in keratinized tissue width at 6 months
|
6 months
|
|
gingival tissue thickness
Time Frame: 6 months
|
changes from baseline in gingival tissue thickness at 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-Dis-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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