N/A N=10 Treatment

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

Alveolar Bone Loss

Bottom Line

View on ClinicalTrials.gov: NCT02255149 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2016

Primary outcome: Primary: Bone Height — 12.2 millimeters

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Bone/Mesh (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Bone Height	12.2	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02255149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.