The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft.
Currently the Connective Tissue Graft (CTG) is referred to as the gold standard in terms of the grafting material for the treatment of gingival recession defects. This study test the non-inferiority of the Allogenic Dermal Matrix (ADM) with Platelet-Rich Fibrin (PRF) to that of the CTG, in terms of the amount of root coverage obtained after the procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Describes the flap design for both treatment arms
University of Michigan - Ann Arbor
Ann Arbor, Michigan, United States
Mean root coverage (mRC)
Measured as a percentage of the total baseline recession defect that coverage was obtained at.
Time frame: Assessed at 6 months
Complete root coverage (CRC)
Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect
Time frame: Assessed at 6 months
Keratinized tissue (KT) gain
Measured in mm
Time frame: Assessed at 6 months
Gingival thickness (GT) gain
Measured in mm
Time frame: Assessed at 6 months
Patient-reported outcomes (PROMs)
In terms of pain/discomfort at the palatal donor site or patient's arm. Measured using a scale from 0 (lowest) to 10 (highest).
Time frame: Measured from the day of the procedure up to a maximum of 1 month
Duration of surgical procedure
Including the length of surgical procedure, drawing of blood, and preparation of PRF, harvesting of the autogenous CTG. Measured in minutes.
Time frame: During surgery
Professionally evaluated esthetic score
Assessed using the Root coverage Esthetic Score (RES) system (from 0 lowest, to 10 highest)
Time frame: Assessed at 6 months
Soft tissue volume changes over time
Assessed using 3D scanner imaging in the units of mm
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Time frame: Changes of from baseline (prior to treatment) compared with 3 and 6 months
Soft tissue volume changes over time
Assessed using dental ultrasonography in the units of mm
Time frame: Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months
Soft tissue blood flow changes over time
Assessed and quantified using dental ultrasonography
Time frame: Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months
Patient-reported esthetics
Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).
Time frame: Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results
Patient-reported satisfaction
Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).
Time frame: Measured at 6 months to provide the satisfaction score in VAS scale
Patient-reported post-operative pain as measured with a mobile application
Measured using a mobile application at the recession grafted site, the donor site on the palate, and the donor site for the venopuncture.
Time frame: From the day of the procedure until 1 month after the surgical time point