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

NCT07713199 | Not Yet Recruiting FDA Device

• 1 other identifier: STUDY00002814
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession Localized Moderate; Dental Implant

Keywords

Tissue graft surgery; Receding gums; Keratinized tissue

Outcome Measures

Primary Outcomes (1)

• Change in width of Keratinized Tissue

  The change in vertical distance from the gingival margin to the keratinized base of the grafted site measured on digital scans, and from the fixed reference point on the customized measurement stent to the keratinized base of the grafted site measured intra-orally.

  Baseline to 6 months

Secondary Outcomes (8)

• Graft dimension width change

  Baseline to 6 months

• Graft Length Change

  Baseline to 6 months

• Dimensional area change

  Baseline to 6 months

• Length of surgery in minutes

  Time to complete surgery (approximately 2-3 hours)

• Numerical rating score for color match

  One month to 6 months

Study Arms (2)

Test Group Porcine Collagen Matrix

ACTIVE COMPARATOR

The recipient site to which the Zderm™ material will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT.

Device: Zderm

Control Group - Palatal Graft

NO INTERVENTION

The recipient site to which the palatal autogenous donor tissue will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT. The harvested tissue will be trimmed to the required size and shape with surgical scissors as indicated by the number of tooth/implant sites to be augmented

Interventions

Zderm DEVICE

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

Test Group Porcine Collagen Matrix

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

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

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Brian L Mealey, DDS, MS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian L Mealey, DDS, MS

CONTACT

210-567-3589; mealey@uthscsa.edu

Angela Palaiologou-Gallis, DDS

CONTACT

210-567-3567; palaiologouA@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized controlled clinical trial examining the results of soft tissue grafting to augment keratinized tissue (KT) using either 1) autogenous soft tissue from the patient's hard palate or 2) a xenograft collagen soft tissue matrix derived from porcine Achilles tendon (Zderm™).

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study end and data analysis is complete.

Locations

US (1)