Microderm for Root Coverage Procedures

Microsurfaced Acellular Dermal Matrix 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Connective Tissue Graft; Gum Recession
• Intervention / Treatment: Biological: MicroDerm; Biological: Alloderm

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mADM; The subjects in this arm will receive microderm as a soft tissue grafting material	Biological: MicroDerm; MicroDerm is an acellular dermal matrix sourced from donated human tissue. Cytoplast™ MicroDerm is micro-surfaced.; Other Names: micro-surfaced acellular dermal matrix
Active Comparator: ADM; The patients in this group will receive alloderm as a soft tissue grafting material	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.; Other Names: donated allograft human dermis; regenerative tissue matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort and aesthetic outcome as perceived by patient	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).	From enrollment to up to one year after connective tissue graft surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood perfusion in the graft	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.	From enrollment to up to one year after connective tissue graft surgery.

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: September 24, 2025
• First Posted (Estimated): October 2, 2025

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Wound healing; treatment outcome; patient comfort; Mouth; Connective Tissue; Tooth root; acellular dermis matrix
• Additional Relevant MeSH Terms: Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Gingival Diseases; Gingival Recession; Alloderm
• Other Study ID Numbers: 2024H0313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes