Vertical and Horizontal Mandibular Ridge Augmentation Techniques

Vertical and Horizontal Mandibular Ridge Augmentation Techniques: A Randomized Controlled Clinical Trial Comparing Customized CAD/CAM Titanium Mesh Versus Reinforced Perforated PTFE Mesh

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).

Study Overview

• Status: Withdrawn
• Conditions: Horizontal Ridge Deficiency; Vertical Ridge Deficiency
• Intervention / Treatment: Procedure: Guided bone regeneration (GBR)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
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); 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 is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	6 months
Rate of complications	Percentage that had complications associated with each technique	6 months
Cost analysis	Difference in cost-effectiveness in dollars	6 months
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	6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Hom-Lay Wang, DDS MSD PhD, Department of Periodontics and Oral Medicine, University of Michigan

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 8, 2024
• First Submitted That Met QC Criteria: October 8, 2024
• First Posted (Actual): October 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2025
• Last Update Submitted That Met QC Criteria: July 21, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HUM00262750

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No