Gingival Recession
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURETunneled coronally advanced flap
Describes the flap design for both treatment arms
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Periodontally and systemically healthy adults * Full-mouth plaque score and full-mouth bleeding score ≤ 20% * Presence of at least one 3 mm or deeper gingival recession, with at least 1.5 mm of Keratinized tissue, and 1 mm of gingival thickness) requiring surgical intervention for root coverage * No interproximal attachment/bone loss * No prior experience of root coverage procedures within the last 1 year * The patient must be able to perform good oral hygiene
Exclusion criteria
* Contraindications for undergoing periodontal surgery * Teeth with more than Grade II mobility, or furcation involvement of Class III * Patients pregnant or attempting to get pregnant (self-reported), or nursing women * Untreated/active periodontitis, or other untreated acute infections at the surgical site * Untreated malignancies at the surgical site * Persistence of uncorrected gingival trauma from traumatic toothbrushing * Presence of severe tooth malposition, rotation or clinically significant super-eruption * Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking, or active tobacco chewing, or chronic vaping * Patients with any known history of blood disorders or complications such as abnormal concentration of thrombin and factor XIII in plasma, or hemophilia * Patients with significant co-morbidities, such as obesity, uncontrolled diabetes, immunosuppression, severe endocrine-induced bone diseases, signs of malnourishment, those receiving immunosuppressive therapy, poor tissue oxygenation or perfusion, and pre- or post-operative radiation * Patients with known sensitivity to Polysorbate 20, Cefoxitin, Lincomycin, polymyxin B, Vancomycin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of surgical procedure | During surgery | Including the length of surgical procedure, drawing of blood, and preparation of PRF, harvesting of the autogenous CTG. Measured in minutes. |
| Mean root coverage (mRC) | Assessed at 6 months | Measured as a percentage of the total baseline recession defect that coverage was obtained at. |
| Complete root coverage (CRC) | Assessed at 6 months | Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect |
| Keratinized tissue (KT) gain | Assessed at 6 months | Measured in mm |
| Gingival thickness (GT) gain | Assessed at 6 months | Measured in mm |
| Patient-reported outcomes (PROMs) | Measured from the day of the procedure up to a maximum of 1 month | In terms of pain/discomfort at the palatal donor site or patient's arm. Measured using a scale from 0 (lowest) to 10 (highest). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported post-operative pain as measured with a mobile application | From the day of the procedure until 1 month after the surgical time point | Measured using a mobile application at the recession grafted site, the donor site on the palate, and the donor site for the venopuncture. |
| Professionally evaluated esthetic score | Assessed at 6 months | Assessed using the Root coverage Esthetic Score (RES) system (from 0 lowest, to 10 highest) |
| Soft tissue volume changes over time | Changes of from baseline (prior to treatment) compared with 3 and 6 months | Assessed using 3D scanner imaging in the units of mm |
| Soft tissue blood flow changes over time | 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 | Assessed and quantified using dental ultrasonography |
| Patient-reported esthetics | Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results | Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest). |
| Patient-reported satisfaction | Measured at 6 months to provide the satisfaction score in VAS scale | Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest). |
Countries
United States
Outcome results
None listed