Recruiting

Soft Tissue Graft

Sponsor:

University of Michigan

Code:

NCT07082244

Conditions

Horizontal Ridge Deficiency

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dental implant placement

Guided bone regeneration with collagen membrane

Guided bone regeneration with acellular dermal matrix.

Study Details

Brief summary:

Single implant sites with bone loss can often be managed by bone grafting alone. The purpose of this study is to determine whether putting a soft tissue graft substitute over the bone graft will provide an increased benefit for improving the health, appearance, and stability of the bone and gums surrounding the implant.

Conditions

Horizontal Ridge Deficiency

Study ID

NCT07082244

Start date

Jun 1, 2025

Status verified date

Jul, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years.
  • Subjects with a physical status of systemically healthy or suffering from mild to moderate, but well-controlled disease; American Society of Anesthesiology (ASA) I or II.
  • Subjects must have one edentulous region, with at least 3 months of healing post-extraction, in the esthetic zone of the maxilla or the premolar and canine region of the mandible. This region includes the maxillary premolars, canines, and incisors.
  • Subjects must have a full mouth plaque and bleeding score of less than or equal to 20%, measured at four sites per tooth.
  • The patients should have a thin periodontal phenotype; bucco-lingual ridge thickness greater than 6mm.
  • Seibert class I deficiency (Seibert, 1983)
  • Patients willing to sign the informed consent.

Exclusion Criteria:

  • Presence of uncontrolled and/or untreated periodontal disease.
  • Patients currently smoking cigarettes, cannabis, and electronic cigarettes.
  • Subjects taking medications known to impact bone metabolism or have the capacity to affect wound healing. These drugs include bisphosphonates, corticosteroids, parathyroid hormone, RANKL inhibitors, past exposure to head and neck radiation, chemotherapy within the last 12 months, among others.
  • Subjects with systemic diseases that impact bone metabolism and wound healing. Namely, osteoporosis, osteopenia, hyperparathyroidism, Paget's disease.
  • Allergy to the graft materials.
  • Pregnant subjects or individuals who self-report as attempting to become pregnant.
  • Patient's unwilling to sign the informed consent.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Guided bone regeneration

Guided bone regeneration with collagen membrane

experimental: Guided bone regeneration with Phenotype modification.

Guided bone regeneration with an allogenic dermal matrix

Interventions

Dental implant placement

Participants will have a dental implant placed at a toothless site

Guided bone regeneration with collagen membrane

Participants will receive guided bone regeneration at a toothless site with bone substitute and a collagen membrane.

Guided bone regeneration with acellular dermal matrix.

Participants will receive guided bone regeneration at a toothless site with bone substitute and an acellular dermal matrix.

Primary outcome measure

  • Horizontal linear change of the buccal bone [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

David Dunbar, DDS

734-763-3346dgdunbar@umich.edu

Alice Ou, RDH, MS

734-763-3346aliceou@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Alice Ou, RDH, MS

(734) 763-3346aliceou@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-30.