Clinical trial NCT05819515: Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix
Official title: Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix, Compared to the Connective Tissue Graft: A Parallel-arm, Randomized, Controlled, Assessor-blind, Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean root coverage (mRC)
timeFrame: Assessed at 6 months
measure: Complete root coverage (CRC)
timeFrame: Assessed at 6 months
measure: Keratinized tissue (KT) gain
timeFrame: Assessed at 6 months
measure: Gingival thickness (GT) gain
timeFrame: Assessed at 6 months
measure: Patient-reported outcomes (PROMs)
timeFrame: Measured from the day of the procedure up to a maximum of 1 month
measure: Duration of surgical procedure
timeFrame: During surgery
Secondary outcomes:
measure: Professionally evaluated esthetic score
timeFrame: Assessed at 6 months
measure: Soft tissue volume changes over time
timeFrame: Changes of from baseline (prior to treatment) compared with 3 and 6 months
measure: Soft tissue volume changes over time
timeFrame: 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
measure: Soft tissue blood flow changes over time
timeFrame: 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
measure: Patient-reported esthetics
timeFrame: Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results
measure: Patient-reported satisfaction
timeFrame: Measured at 6 months to provide the satisfaction score in VAS scale
measure: Patient-reported post-operative pain as measured with a mobile application
timeFrame: From the day of the procedure until 1 month after the surgical time point
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan - Ann Arbor
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hom-Lay Wang, DDS MSD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Shayan Barootchi, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barootchi S, Tavelli L. Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Int J Esthet Dent. 2022 Feb 17;17(1):14-26.
citation: Barootchi S, Giannobile WV, Tavelli L. PDGF-BB-enriched collagen matrix to treat multiple gingival recessions with the tunneled coronally advanced flap. Clin Adv Periodontics. 2022 Dec;12(4):224-232. doi: 10.1002/cap.10211. Epub 2022 Oct 24.
citation: Tavelli L, Barootchi S. A Minimally Invasive Approach for the Treatment of Multiple Adjacent Gingival Recessions with a Volume-Stable Collagen Matrix: A Case Series. Int J Periodontics Restorative Dent. 2022 Mar-Apr;42(2):155-162. doi: 10.11607/prd.5747.