Vertical and Horizontal Mandibular Ridge Augmentation Techniques

NCT06636084 | Withdrawn

• 1 other identifier: HUM00262750
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Vertical Ridge Deficiency; Horizontal Ridge Deficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in the mucosal thickness in mm

  6 months

• Histological outcomes of the augmented bone

  6 months

• The volumetric bone gain of the grafted area in mm3

  6 months

• Rate of complications

  6 months

• Cost analysis

  6 months

Study Arms (2)

Customized CAD/CAM Titanium Mesh

EXPERIMENTAL

A customized CAD/CAM Titanium Mesh will be used to cover the bone graft

Procedure: Guided bone regeneration (GBR)

Reinforced Perforated PTFE Mesh (RPM)

ACTIVE COMPARATOR

A Reinforced Perforated PTFE Mesh membrane will be used to cover the bone graft

Procedure: Guided bone regeneration (GBR)

Interventions

Guided bone regeneration (GBR) PROCEDURE

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.

Customized CAD/CAM Titanium Mesh; Reinforced Perforated PTFE Mesh (RPM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Hom-Lay Wang, DDS MSD PhD

  Department of Periodontics and Oral Medicine, University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Collegiate Professor of Periodontics and Professor of Dentistry

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)