Improve implant site by adding a soft-tissue graft substitute over a bone graft

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.