Free Soft Tissue Grafts FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07713199
Status
Not Yet Recruiting

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Conditions

  • Dental Implant
  • Gingival Recession Localized Moderate

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Zderm — DEVICE
    The material used at the graft recipient site is xenograft collagen soft tissue matrix derived from porcine Achilles tendon (ZdermTM)

Study Details

Participant in this study are asked to participate because they have teeth or dental implants that were identified as having very little gum tissue and would benefit from gum tissue graft surgery. This study has 2 treatment groups that differ only in the material that will be used at the graft site: * Gum tissue taken from the patient's own palate * Commercially available collagen matrix derived from porcine (pig) Achilles tendon (FDA-approved for the surgery done in this study). Both materials have been in use in dental practices for many years, but no studies have directly compared the outcomes between palatal tissue and the porcine collagen matrix we will use in this study. Participants will be randomized into one of the 2 groups using sealed envelopes (the process is like flipping a coin). All the study visits will take place during regular dental appointments that would be scheduled even if not participating in this research.

Key Dates

First listed
Jul 20, 2026
Start date
Sep 15, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Test Group Porcine Collagen Matrix
    The recipient site to which the Zderm™ material will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT.
  • No Intervention: Control Group - Palatal Graft
    The recipient site to which the palatal autogenous donor tissue will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT. The harvested tissue will be trimmed to the required size and shape with surgical scissors as indicated by the number of tooth/implant sites to be augmented

Primary Outcome Measure

Change in width of Keratinized Tissue [ Time Frame: Baseline to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Health Science Center at San Antonio School of DentistrySan AntonioTexas78229
Brian L Mealey, DDS, MS
[email protected]
210-567-3318
Angela Palaiologou-Gallis, DDS
[email protected]
210-567-3589

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By research site
University of Texas Health Science Center at San Antonio School of Dentistry· San Antonio, TX

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