Vertical and Horizontal Mandibular Ridge Augmentation Techniques

University of Michigan

Status: Withdrawn

Conditions: Vertical Ridge Deficiency; Horizontal Ridge Deficiency

Treatments: Procedure: Guided bone regeneration (GBR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06636084

HUM00262750

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Customized CAD/CAM Titanium Mesh

Experimental group

Description:

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

Treatment:

Procedure: Guided bone regeneration (GBR)

Reinforced Perforated PTFE Mesh (RPM)

Active Comparator group

Description:

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

Treatment:

Procedure: Guided bone regeneration (GBR)