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

NCT07713199 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-07-20

No results posted yet for this study

Summary

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.

Conditions

  • Gingival Recession Localized Moderate
  • Dental Implant

Interventions

DEVICE

Zderm

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

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Brian L Mealey, DDS, MS · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2028-10-31
Completion
2029-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07713199 on ClinicalTrials.gov