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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Zderm

Treatment groups

68 Participants
are divided into 2 treatment groups