Improve implant site by adding a soft-tissue graft substitute over a bone graft
Phenotype Modification Via Guided Bone Regeneration and Acellular Dermal Matrix Simultaneous to Delayed Implant Placement: A Double Arm Randomized Controlled Clinical Trial.
We will test whether placing a soft-tissue graft substitute (acellular dermal matrix) over a bone graft at single implant sites helps improve the bone and gum health, appearance, and stability for adults with horizontal ridge deficiency.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT07082244 on ClinicalTrials.gov |
What this trial studies
Adults needing a single implant at a previously healed edentulous site (>3 months post-extraction) will receive implant placement with guided bone regeneration (GBR) using a collagen membrane and bone graft. Half of participants will also receive an acellular dermal matrix (ADM) soft-tissue graft substitute placed over the grafted site. Outcomes will include measures of bone and soft-tissue health, esthetic appearance, and stability of the peri-implant tissues over follow-up visits. The protocol excludes current smokers, patients with uncontrolled periodontal disease, and those on medications known to affect bone healing.
Who should consider this trial
Good fit: Adults (≥18 years) with one healed edentulous region in the anterior maxilla or premolar/canine mandible (≥3 months post-extraction), a thin periodontal phenotype with Seibert Class I horizontal ridge deficiency, good oral hygiene, and ASA I–II health status.
Not a fit: Patients with uncontrolled or untreated periodontal disease, current smokers (including cannabis and e-cigarettes), or those taking medications that impair bone healing are unlikely to benefit and may be excluded.
Why it matters
Potential benefit: If successful, adding an ADM over GBR could improve soft-tissue thickness, esthetics, and long-term stability around single dental implants.
How similar studies have performed: Previous work combining GBR with soft-tissue substitutes like ADM has shown some positive effects on soft-tissue thickness and esthetics, but results are mixed and high-quality controlled data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Muhammad Saleh, BDS, MSD — University of Michigan
- Study coordinator: David Dunbar, DDS
- Email: dgdunbar@umich.edu
- Phone: 734-763-3346
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.