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

Completed · Not applicable

Conditions studied: Gingival Recession

In brief

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.

Key facts

Study ID

NCT05819515

Run by

University of Michigan

People needed

36

Starts

2023-04-29

Expected to finish

2024-03-27

Last updated by the study team

2024-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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