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

Official title

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

Overview

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.

Detailed 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 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 animal tissue approach. The purpose of this study is to compare the 2 approaches during a period of 6 months after graft surgery to determine if the change in gingiva is similar or different between the 2 approaches.

Teeth are surrounded by soft tissue called gingiva (gums). Sometimes, the amount of gingiva is very small, which can lead to problems such as receding gums, pain on toothbrushing/flossing, and an increased risk for gum diseases. In such instances, dentists commonly perform surgery procedures to increase the amount of gum tissue around teeth or dental implants. "Gum grafting" involves taking a small piece of tissue from one location (called the donor site and donor tissue) and transplanting it to the area where the amount of gingiva is inadequate (called the recipient site because this location will receive the donor tissue).

Interventions

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

Primary outcome measures

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

Secondary outcome measures (8)

• Graft dimension width change [Time frame: Baseline to 6 months]
• Graft Length Change [Time frame: Baseline to 6 months]
• Dimensional area change [Time frame: Baseline to 6 months]
• Length of surgery in minutes [Time frame: Time to complete surgery (approximately 2-3 hours)]
• Numerical rating score for color match [Time frame: One month to 6 months]
• San Antonio Texture index (SaTi) [Time frame: One month to six months]
• Pain Score on Numeric Rating Scale (NRS) [Time frame: 24 to 168 hours after surgery]
• Analgesic consumption [Time frame: 24 to 168 hours]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Texas Health Science Center at San Antonio School of Dentistry — San Antonio

Identifiers

NCT: NCT07713199 · STUDY00002814

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗