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

University of Michigan

Status

Completed

Conditions

Gingival Recession

Treatments

Procedure: Tunneled coronally advanced flap

Study type

Interventional

Funder types

Other

Identifiers

NCT05819515

HUM00214311

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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