Microderm for Root Coverage Procedures

The Ohio State University

Status and phase

Active, not recruiting

Phase 4

Conditions

Gum Recession

Connective Tissue Graft

Treatments

Biological: MicroDerm

Biological: Alloderm

Study type

Interventional

Funder types

Other

Identifiers

NCT07203326

2024H0313

Details and patient eligibility

About

This randomized pilot study will compare Acellular Dermal Matrix (ADM) and a microsurfaced Acellular Dermal Matrix (mADM) for wound healing, root coverage, gum tissue coverage of the surgical site, blood flow to the site, and patient comfort.

Full description

Advancements in Periodontal Surgery techniques and materials have continuously progressed to improve patient dental health. While the patient's own gum tissue from another site of the mouth as a graft [subepithelial connective tissue graft (SCTG)] remains the benchmark for tooth root coverage and increasing gum tissue, there are disadvantages to this surgical method. One disadvantage with this surgical method is the patient will have two surgical sites, one for the graft and one for the coverage of the exposed roots. Another disadvantage, there is limited tissue on the roof of the mouth for covering multiple exposed roots, which means multiple surgeries to cover all the exposed roots. For over 25 years, connective tissue graft surgery using Acellular Dermal Matrix (ADM) has served as an alternative to tissue grafts using the patient's own tissues. ADM is a processed material often used in gum surgery to avoid taking tissue from another part of the mouth) While ADM may not match SCTG for stability and gain in gum tissue, ADM remains a viable alternative to SCTG. Recently, a new ADM [microsurfaced Acellular Dermal Matrix (mADM)] has been developed to enhance healing and improve the surgical outcome. This randomized pilot study will compare ADM and mADM for wound healing, root coverage, gum tissue coverage of the surgical site, blood flow to the site, and patient comfort.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants 18+ years of age who require a tissue graft due to gum tissue recession.

Exclusion criteria

Current smokers or users of nicotine replacement products
Patients with diabetes (HbA1c > 5.6%)
Pregnant or lactating women
Surgical sites with previous soft tissue graft.
Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
Patients who are taking anticoagulant and antiplatelet medications.
Patients with contraindications, e.g., allergy, for any of the medications used in the study (benzocaine, lidocaine, chlorhexidine rinse, ibuprofen)
Poor oral hygiene (PII >2)