WithdrawnNCT06636084Updated Jul 25, 2025

Vertical and Horizontal Mandibular Ridge Augmentation Techniques

An interventional study of Guided bone regeneration (GBR) in Vertical Ridge Deficiency and Horizontal Ridge Deficiency, sponsored by University of Michigan. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by University of Michigan · Not applicable, Interventional, and Treatment

Why this study was withdrawn

Lack of funding

Phase: Not applicable
Study type: Interventional
Enrollment: 0
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to compare alveolar ridge augmentation outcomes of two types of membranes for vertical and horizontal mandibular ridge augmentation: Customized CAD/CAM Titanium Mesh versus Reinforced Perforated PTFE Mesh (RPM).

Conditions studied

Vertical Ridge Deficiency
Horizontal Ridge Deficiency

In context

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Age ≥ 18 years
Physical status according to the American Society of Anesthesiology (ASA) I or II, which includes patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
Subjects having at least one free end saddle edentulous area of the posterior area of the mandible with moderate horizontal and vertical bone defects >≥3mm.
Capacity to understand and accept the written conditions of the study.

Exclusion criteria

Exclusion Criteria:

Insufficient oral hygiene.
Smoking habit of >10 cigarettes/day (self-reported).
Abuse of alcohol or drugs.
Pregnancy or individuals attempting to get pregnant (self-reported).
Acute local or systemic infections.
Uncontrolled diabetes or other metabolic disease.
Severe hepatic or renal dysfunction.
Autoimmune disorders.
Patients who underwent radiotherapy in the last 5 years.
Patients undergoing immunosuppressive therapy or who are immunocompromised.
Any other contraindications for undergoing surgery.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 0 participants (actual)

Study arms

Experimental
Customized CAD/CAM Titanium Mesh
A customized CAD/CAM Titanium Mesh will be used to cover the bone graft
Procedure: Guided bone regeneration (GBR)
Active comparator
Reinforced Perforated PTFE Mesh (RPM)
A Reinforced Perforated PTFE Mesh membrane will be used to cover the bone graft
Procedure: Guided bone regeneration (GBR)

Interventions

ProcedureGuided bone regeneration (GBR)
A composite graft composed of a 50:50 proportion of autogenous bone and a demineralized bone mineral will be positioned around the bony defect or placed in the membrane, depending on the group randomization. The selected membrane will then be secured with screws to ensure a complete and stable coverage of the grafted area.

What researchers measure

Primary outcomes

Ridge width changes in mm
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
Time frame: 6 months
Ridge height changes in mm
Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements
Time frame: 6 months

Secondary outcomes

Change in the mucosal thickness in mm
Change in the mucosal thickness due to the provided space from baseline to the surgical mesh removal using an ultrasound
Time frame: 6 months
Histological outcomes of the augmented bone
In terms of the amount of newly formed vital bone, residual graft particles, and connective tissue (CT)/other non-mineralized tissue components as a percentage
Time frame: 6 months
The volumetric bone gain of the grafted area in mm3
Radiographic changes of bone volume based on cone-beam computed tomography (CBCT) scan measurements
Time frame: 6 months
Rate of complications
Percentage that had complications associated with each technique
Time frame: 6 months
Cost analysis
Difference in cost-effectiveness in dollars
Time frame: 6 months

Study locations

1 site

University of Michigan School of Dentistry
Ann Arbor, Michigan 48109, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06636084
Lead sponsor: University of Michigan
Responsible party: Hom-Lay Wang, DDS, MSD, Ph D (Collegiate Professor of Periodontics and Professor of Dentistry, University of Michigan) — Principal investigator
First posted: Oct 10, 2024
Start date: Dec 1, 2025 (estimated)
Primary completion: Jan 1, 2027 (estimated)
Completion: Jun 1, 2027 (estimated)
Last update: Jul 25, 2025

Study contacts

Hom-Lay Wang, DDS MSD PhD

principal investigator · Department of Periodontics and Oral Medicine, University of Michigan

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of Michigan

Start the discussion