Vertical and Horizontal Mandibular Ridge Augmentation Techniques

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-06-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Vertical Ridge Deficiency Horizontal Ridge Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Customized CAD/CAM Titanium Mesh

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

Group Type EXPERIMENTAL

Guided bone regeneration (GBR)

Intervention Type 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.

Reinforced Perforated PTFE Mesh (RPM)

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

Group Type ACTIVE_COMPARATOR

Guided bone regeneration (GBR)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes