Microderm for Root Coverage Procedures

NCT07203326 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024H0313
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Connective Tissue Graft; Gum Recession

Keywords

Connective Tissue; Wound healing; Tooth root; Mouth; patient comfort; treatment outcome; acellular dermis matrix

Outcome Measures

Primary Outcomes (1)

• Clinical root coverage in percentage

  To compare the wound healing of root coverage procedures, and the gain of root coverage using either a new microsurfaced Acellular Dermal Matrix(mADM) or Acellular Dermal Matrix (ADM).

  From enrollment to up to one year after connective tissue graft surgery.

Secondary Outcomes (1)

• Comfort and aesthetic outcome as perceived by patient

  From enrollment to up to one year after connective tissue graft surgery.

Other Outcomes (1)

• Blood perfusion in the graft

  From enrollment to up to one year after connective tissue graft surgery.

Study Arms (2)

mADM

EXPERIMENTAL

The subjects in this arm will receive microderm as a soft tissue grafting material

Biological: MicroDerm

ADM

ACTIVE COMPARATOR

The patients in this group will receive alloderm as a soft tissue grafting material

Biological: Alloderm

Interventions

Alloderm BIOLOGICAL

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.

Also known as: donated allograft human dermis, regenerative tissue matrix

ADM

MicroDerm BIOLOGICAL

MicroDerm is an acellular dermal matrix sourced from donated human tissue. Cytoplast™ MicroDerm is micro-surfaced.

Also known as: micro-surfaced acellular dermal matrix

mADM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Dentistry

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Alloderm

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant and blinded evaluator will be not be told which treatment area received which treatment (Alloderm or Microderm). Outcome assessor will not know the group rendering.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: February 13, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)