Free Soft Tissue Grafts FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™) | NCT07713199

NCT07713199

Overview

NCT ID: NCT07713199
Lead Sponsor: The University of Texas Health Science Center at San AntonioOTHER
Official Title: Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Soft Tissue Matrix From Porcine Achilles Tendon (Zderm™)
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 20, 2026Actual
Start Date: Sep 15, 2026Estimated
Primary Completion Date: Oct 31, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Male or female patient aged 18 to 89

One or more teeth/dental implants, excluding 3rd molars, that have been identified by dental faculty as requiring augmentation of KT

A FSTG is indicated and treatment planned to augment the KT. Coverage of exposed root surfaces is not indicated or intended. Patients needing root coverage surgical procedures re not eligible for enrollment (similar to our past studies, see references 11,12)

Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential as eligible.

Patients who are nonsmokers or former smokers are eligible. Current smokers may also be included if they smoke <10 cigarettes per day (less than or equal to 10 cigarettes per day).

Exclusion Criteria:

Patients with a known allergy to collagen of animal origins.

Patients who will not cooperate with the follow-up schedule.

Patients will not be entered who are mentally incompetent, prisoners, or pregnant.

Patients who require soft tissue grafting specifically to treat exposed root coverage (gingival recession)

Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over-the-counter pregnancy test will be provided if pregnancy status is unknown or suspected).

Patients who become pregnant during the study will be withdrawn and standard care will be delivered.

Patients with active or systemic infections other than periodontitis; a disease entity, condition or therapeutic regimen which decreases probability of soft tissue healing, e.g., poorly controlled diabetes, autoimmune diseases, long-term steroid therapy.

Smokers who smoke >10 cigarettes per day (more than 10 cigarettes per day)

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 68Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Brian L Mealey, DDS, MSContact
mealey@uthscsa.edu210-567-3589

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

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