Vertical and Horizontal Mandibular Ridge Augmentation Techniques

Not Applicable

Not yet recruiting

• Conditions: Vertical Ridge Deficiency; Horizontal Ridge Deficiency
• Interventions: Procedure: Guided bone regeneration (GBR)

• Registration Number: NCT06636084
• Lead Sponsor: University of Michigan

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-08
• Study First Posted: 2024-10-10
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Study Start: 2025-06-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Customized CAD/CAM Titanium Mesh	Guided bone regeneration (GBR)	A customized CAD/CAM Titanium Mesh will be used to cover the bone graft
Reinforced Perforated PTFE Mesh (RPM)	Guided bone regeneration (GBR)	A Reinforced Perforated PTFE Mesh membrane will be used to cover the bone graft

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The volumetric bone gain of the grafted area in mm3	6 months	Radiographic changes of bone volume based on cone-beam computed tomography (CBCT) scan measurements
Rate of complications	6 months	Percentage that had complications associated with each technique
Cost analysis	6 months	Difference in cost-effectiveness in dollars
Change in the mucosal thickness in mm	6 months	Change in the mucosal thickness due to the provided space from baseline to the surgical mesh removal using an ultrasound
Histological outcomes of the augmented bone	6 months	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

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States