Implant Phenotype Modification Via GBR and ADM

University of Michigan

Status: Not yet enrolling

Conditions: Horizontal Ridge Deficiency

Treatments: Procedure: Guided bone regeneration with acellular dermal matrix.; Procedure: Guided bone regeneration with collagen membrane; Procedure: Dental implant placement

Study type: Interventional

Funder types: Other

Identifiers

NCT07082244

HUM00262601

Details and patient eligibility

About

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.

Full description

The study will treat patients that need a single implant at a previously edentulous site (>3 months post extraction) that requires phenotypic modification. These patients will receive an implant with simultaneous GBR, with half of the participants also receiving an ADM graft.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Guided bone regeneration

Active Comparator group

Description:

Guided bone regeneration with collagen membrane

Treatment:

Procedure: Dental implant placement

Procedure: Guided bone regeneration with collagen membrane

Guided bone regeneration with Phenotype modification.

Experimental group

Description:

Guided bone regeneration with an allogenic dermal matrix

Treatment:

Procedure: Dental implant placement

Procedure: Guided bone regeneration with acellular dermal matrix.