NCT07203326

Microderm for Root Coverage Procedures

Microsurfaced Acellular Dermal Matrix for Root Coverage Procedures

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Connective Tissue Graft
• Gum Recession

Interventions

Type	Name	Description
BIOLOGICAL	Alloderm	Alloderm is a ready to use tissue graft, made from donated allograft human dermis, processed to remove cells while preserving biologic components and structure of the dermal matrix.
BIOLOGICAL	MicroDerm	MicroDerm is an acellular dermal matrix sourced from donated human tissue. Cytoplast™ MicroDerm is micro-surfaced.

Timeline

• Start date: 2025-02-13
• Primary completion: 2026-08-31
• Completion: 2026-12-01
• First posted: 2025-10-02
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study