Implant Phenotype Modification Via GBR and ADM

Not Applicable

Not yet recruiting

• Conditions: Horizontal Ridge Deficiency

• Registration Number: NCT07082244
• Lead Sponsor: University of Michigan

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2025-08-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Horizontal linear change of the buccal bone	6 months	Radiographic changes of bone level in mm based on cone-beam computed tomography

Secondary Outcome Measures

Name	Time	Method
The volumetric changes of the facial soft tissue	6 months	Volumetric changes in mm\^3 based on intraoral digital scans
Histological bone density	6 months	Histomorphometry
The vascular changes of the facial soft tissue	6 months	Vascular changes in mm\^3 based on ultrasound scans
Peri-implant health, as defined by clinical attachment level.	6 months	Changes in clinical attachment level measurements in mm
Patient-reported morbidity, satisfaction and comfort using a visual analogue scale (VAS)	6 months	Difference in survey results
Clinician-reported overall treatment effectiveness	6 months	Scale from 1 (Poor) to 5 (Excellent)