Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions
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|ClinicalTrials.gov Identifier: NCT01793389|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : August 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Gingival Recession||Procedure: Subepithelial connective tissue graft Procedure: Platelet Rich Fibrin||Not Applicable|
The main objective of this split-mouth, randomized, controlled clinical trial was to compare the clinical efficacy of platelet rich fibrin (PRF) in combination with the coronally advanced flap (CAF) to the use of subepithelial connective tissue graft (SCTG) in combination with CAF in the treatment of localized gingival recessions.
Primary outcome variables were percentage of complete root coverage and change in gingival recession expressed as recession reduction in millimeters at follow-up visits. The secondary outcome variables included keratinized tissue and gingival thickness gain.
Sample size has been estimated in 22 subjects per treatment groups. Random allocation of the treatment sites to test (CAF+ PRF) and control (CAF + SCTG) groups will be performed using a computerized selection of random numbers for allocation of the study groups.
Periodontal parameters including plaque index (25) (PI), gingival index (26) (GI), probing depth (PD), clinical attachment level (CAL), and gingival recession parameters including recession depth (RD), recession width (RW), recession area (RA), keratinized tissue width (KTW), gingival thickness (GT) were assessed by a calibrated examiner. At baseline and 1, 3 and 6 months, RD, RW, RA, KTW were evaluated by means of both clinical and digital assessment. GI and PI were recorded at baseline and 1, 3 and 6 months, however PD, CAL, and GT were evaluated at baseline and 6 months. PD and CAL were recorded by a Williams probe accurate to the nearest 0.5 mm. GT was evaluated at baseline and 6 months using #15 endodontic reamer attached to a rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness was measured to the nearest 0.1 mm using a caliper.
Clinical images obtained at baseline and 1, 3 and 6 months after surgery from each treatment site and digitized in a computer image analysis system. Using a 4-mm length wire was used to check the reproducibility of the pictures. RD was measured from the cement-enamel junction (CEJ) to the gingival margin, RW was measured tangentially at the mid-facial CEJ, RA was calculated as the area within the contour of denuded root. KTW recorded as the distance from the mucogingival junction (MGJ) to the gingival margin. Duplicate measurements were made for RD, RW, RA and KTW. Percent root coverage and complete root coverage was calculated RA according to the following standard formulae.
Follow-up of subjects will be 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Platelet Rich Fibrin in the Treatment of Localized Gingival Recessions: Split-mouth Randomized Clinical Trial|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Active Comparator: Subepithelial connective tissue graft
Soft tissue harvested from palatum of the subjects.
Procedure: Subepithelial connective tissue graft
Experimental: Platelet Rich Fibrin
Autogenous platelet and leukocyte fibrin material was obtained from blood.
Procedure: Platelet Rich Fibrin
- Complete root coverage [ Time Frame: 1, 3 and 6 months ]Change from baseline in percentage of complete root coverage at 1, 3 and 6 months.
- Gingival recession depth [ Time Frame: 1, 3 and 6 months ]Change from baseline in gingival recession will be assessed at 1, 3 and 6 months.
- Keratinized tissue width [ Time Frame: 6 months ]Change from baseline in keratinized tissue at 6 months.
- Gingival thickness [ Time Frame: 6 months ]Change from baseline in gingival thickness at 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793389
|Ege University School of Dentistry Department of Periodontology|
|İzmir, Turkey, 35100|
|Principal Investigator:||Gülnihal Eren, PhD||Ege University School of Dentistry|
|Study Director:||Gül Atilla, Professor||Ege University School of Dentistry|