Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07203326

Microderm for Root Coverage Procedures

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Connective Tissue Graft Gingival Diseases Gingival Recession Gum Recession Mouth Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Ohio State University College of Dentistry

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: donated allograft human dermis, regenerative tissue matrix

MicroDerm

Biological

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

Other names: micro-surfaced acellular dermal matrix

Primary outcomes

  1. Clinical root coverage in percentage

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

    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).

Secondary outcomes

  1. Comfort and aesthetic outcome as perceived by patient

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

    By using a Visual Analog Scale (VAS) for Pain and a VAS for aesthetics, patients will note their comfort and appearance of the surgical site at different points after surgery. Scale for pain is from 0 (no pain) to 10 (worse pain imaginable). Scale for aesthetic is 0 (not meeting expectation/unnatural looking/no improvement) to 10 (perfect/natural/significant improvement).

Other outcomes

  1. Blood perfusion in the graft

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

    Through the use of laser speckle contrast imaging (LASCA), the blood perfusion of the surface of the gum tissue/graft area will be recorded. LASCA is a non-invasive technique that maps blood flow in real-time by analyzing the fluctuations in a laser-generated speckle pattern, which is affected by moving red blood cells. This method provides two-dimensional perfusion maps, making it useful for studying and monitoring blood flow in tissues and organs without contrast agents.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Microsurfaced Acellular Dermal Matrix for Root Coverage Procedures

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.