Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix

Not Applicable

Completed

• Conditions: Gingival Recession
• Interventions: Procedure: Tunneled coronally advanced flap

• Registration Number: NCT05819515
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-19
• Study Start: 2023-04-29
• Primary Completion: 2024-03-27
• Study Completion: 2024-03-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allogenic Dermal Matrix with Platelet-Rich Fibrin	Tunneled coronally advanced flap	An allogenic dermal matrix with the patient's platelet-rich fibrin will be used
Connective Tissue Graft	Tunneled coronally advanced flap	A connective tissue graft from the patient's palate will be used

Primary Outcome Measures

Name	Time	Method
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
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.
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 Outcome Measures

Name	Time	Method
Soft tissue volume 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 using dental ultrasonography in the units of mm
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.
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).
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 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 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).

Trial Locations

Locations (1)

University of Michigan - Ann Arbor; 🇺🇸 Ann Arbor, Michigan, United States