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COMPLETEDNA

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

NCT05819515•University of Michigan

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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
+1 more criteria

Locations (1)

University of Michigan - Ann Arbor

Ann Arbor, Michigan, United States

Key Dates

Start Date

April 29, 2023

Primary Completion Date

March 27, 2024

Completion Date

March 27, 2024

Last Updated

July 12, 2024

Enrollment

ACTUAL participants

Conditions

Gingival Recession

Interventions

Tunneled coronally advanced flap

PROCEDURE

A Novel Volume Stable Matrix for Gingival Recession Coverage at Teeth

NCT07437417

Gingival RecessionConnective Tissue Defect

View study

RECRUITINGNA

Changes in Soft Tissue Thickness Following Multiple Coronally Advanced Tunnel (MCAT) vs Vestibular Incision Subperiosteal Tunnel Access (VISTA)

NCT07200258

Gingival Recession

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Novel Volume Stable Matrix for Gingival Recession Coverage at Teeth

Changes in Soft Tissue Thickness Following Multiple Coronally Advanced Tunnel (MCAT) vs Vestibular Incision Subperiosteal Tunnel Access (VISTA)

Comparing TCAF and MTUN With Soft Tissue Grafting for Treating Single Recessions in the Premandible

NovoMatrix in Gingival Recession Coverage: Case Series

Effectiveness of Micro Connective Tissue Graft for Treatment of Multiple Adjacent Gingival Recession Defects

Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries