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

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

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.

Study Overview

• Status: Completed
• Conditions: Gingival Recession
• Intervention / Treatment: Procedure: Tunneled coronally advanced flap

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan - Ann Arbor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Connective Tissue Graft; A connective tissue graft from the patient's palate will be used	Procedure: Tunneled coronally advanced flap; Describes the flap design for both treatment arms
Experimental: Allogenic Dermal Matrix with Platelet-Rich Fibrin; An allogenic dermal matrix with the patient's platelet-rich fibrin will be used	Procedure: Tunneled coronally advanced flap; Describes the flap design for both treatment arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean root coverage (mRC)	Measured as a percentage of the total baseline recession defect that coverage was obtained at.	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	Assessed at 6 months
Keratinized tissue (KT) gain	Measured in mm	Assessed at 6 months
Gingival thickness (GT) gain	Measured in mm	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).	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.	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Professionally evaluated esthetic score	Assessed using the Root coverage Esthetic Score (RES) system (from 0 lowest, to 10 highest)	Assessed at 6 months
Soft tissue volume changes over time	Assessed using 3D scanner imaging in the units of mm	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	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	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).	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).	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.	From the day of the procedure until 1 month after the surgical time point

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Hom-Lay Wang, DDS MSD PhD, University of Michigan; Principal Investigator: Shayan Barootchi, DMD, MS, University of Michigan

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2023
• Primary Completion (Actual): March 27, 2024
• Study Completion (Actual): March 27, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Periodontal Atrophy; Gingival Recession
• Other Study ID Numbers: HUM00214311

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No