Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Soft Tissue Matrix From Porcine Achilles Tendon (Zderm™)
The University of Texas Health Science Center at San Antonio
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 groups that differ only in the material that will be used at the graft site: * Gum tissue taken from the patient's own palate (standard of care group) * 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.
Description
The investigators are examining the amount of gingiva gained when using 2 different types of donor tissue to do the graft surgery: either gum tissue from the patient's palate (standard of care) or commercially available tissue called a "collagen matrix" that comes from an animal source (the Achilles tendon of pigs). Palatal tissue has been used for over 70 years for this purpose, while animal sources have been used for about 15 years. So far, no studies have been done to see if there are any differences in the amount of new gum tissue we see when we use the palatal tissue approach versus the a…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceZderm
The material used at the graft recipient site is xenograft collagen soft tissue matrix derived from porcine Achilles tendon (ZdermTM)
Location
- University of Texas Health Science Center at San Antonio School of DentistrySan Antonio, Texas