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

Not Applicable

Completed

• Conditions: Alveolar Bone Loss
• Interventions: Device: Bone/Mesh

• Registration Number: NCT02255149
• Lead Sponsor: University of Michigan

Brief Summary

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

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

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2016-03-17
• Results First Submitted QC: 2016-03-17
• Results First Posted: 2016-04-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bone/Mesh	Bone/Mesh	Allograft and Titanium mesh will be used to grow jaw bone vertically.

Primary Outcome Measures

Name	Time	Method
Bone Height	5 months	Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.