Horizontal Ridge Deficiency, Vertical Ridge Deficiency
Conditions
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).
Interventions
PROCEDUREGuided 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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ridge width changes in mm | 6 months | Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements |
| Ridge height changes in mm | 6 months | Radiographic changes of the ridge width based on cone-beam computed tomography (CBCT) scan measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Cost analysis | 6 months | Difference in cost-effectiveness in dollars |
| Rate of complications | 6 months | Percentage that had complications associated with each technique |
| 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 |
Countries
United States
Outcome results
None listed