Implant Phenotype Modification Via GBR and ADM

NCT07082244 | Recruiting

• 1 other identifier: HUM00262601
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Horizontal linear change of the buccal bone

  Radiographic changes of bone level in mm based on cone-beam computed tomography

  6 months

Secondary Outcomes (6)

• The volumetric changes of the facial soft tissue

  6 months

• The vascular changes of the facial soft tissue

  6 months

• Peri-implant health, as defined by clinical attachment level.

  6 months

• Patient-reported morbidity, satisfaction and comfort using a visual analogue scale (VAS)

  6 months

• Clinician-reported overall treatment effectiveness

  6 months

Study Arms (2)

Guided bone regeneration

ACTIVE COMPARATOR

Guided bone regeneration with collagen membrane

Procedure: Dental implant placement; Procedure: Guided bone regeneration with collagen membrane

Guided bone regeneration with Phenotype modification.

EXPERIMENTAL

Guided bone regeneration with an allogenic dermal matrix

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

Interventions

Dental implant placement PROCEDURE

Participants will have a dental implant placed at a toothless site

Guided bone regeneration; Guided bone regeneration with Phenotype modification.

Guided bone regeneration with collagen membrane PROCEDURE

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

Guided bone regeneration

Guided bone regeneration with acellular dermal matrix. PROCEDURE

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

Guided bone regeneration with Phenotype modification.

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

• Muhammad Saleh, BDS, MSD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Dunbar, DDS

CONTACT

734-763-3346; dgdunbar@umich.edu

Alice Ou, RDH, MS

CONTACT

734-763-3346; aliceou@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Dentistry, Department of Periodotnics and Oral Medicine, School of Dentistry

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: July 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)