A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw

Study Overview
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Brief Summary
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This study will involve placing donor bone into the back of lower jaw then covering with a newly designed titanium mesh. The mesh will then stay in the mouth for 4 months before it will be removed. Implants will be placed in the newly formed bone. The goal of this study is to test how well using a newly designed titanium mesh and bone particles can grow bone in the back of the lower jaw. The investigators are also checking if the newly formed bone will stay around implants that will have been in use for 12 months.

Detailed Description
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Inclusion Criteria Patients are at least 18 years old At least two adjacent back teeth in the lower jaw are missing No medical contraindication to dental surgery Inadequate vertical ridge height at edentulous region (less than 10mm) Exclusion Criteria Unstable systemic diseases or conditions that would compromise the healing potential Patients with osseous metabolic disorders (e.g., osteoporosis, Paget's disease etc.) Patients who are pregnant or expect to get pregnant Patients with unstable dental disease (e.g. caries and periodontitis) in the surgical sextant

Official Title
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Vertical Ridge Augmentation Using Titanium Mesh and Allograft in Posterior Mandible: A Feasibility Study

Conditions
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Alveolar Bone Loss

Intervention / Treatment
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* Device: Bone/Mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Systemically healthy patients (ASA I or II) Non-smoker or light smokers (< 10 cigarettes per day) Good oral health (FMPS and FMBS <20%) At least two adjacent mandibular posterior teeth are missing Inadequate vertical ridge height at edentulous region (less than 10mm) Missing teeth for ≥ 3 months Exclusion Criteria: Unstable and complicated systemic diseases or chronic disorders precluding surgical procedures Systemic diseases with compromised healing potentials (Uncontrolled Diabetes Mellitus, HIV infections, etc.) Bone disorders (Hyperparathyroidism, Osteoporosis, Paget's Disease) Pregnant or expecting to become pregnant Currently smoking (≥ 10 cigarettes/day) Poor oral hygiene (≥20% Modified O'Leary Plaque Index) Severe grinding, clenching, TMJ disorder Untreated dental disease (periodontitis, caries, abscesses) in the research quadrant Teeth exhibiting periapical pathology or purulence (symptomatic) in the research quadrant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bone/Mesh<br>Allograft and Titanium mesh will be used to grow jaw bone vertically. | Device: Bone/Mesh<br>* A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Height | Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images. | 5 months |