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

University of Michigan logo

University of Michigan

Status

Completed

Conditions

Alveolar Bone Loss

Treatments

Device: Bone/Mesh

Study type

Interventional

Funder types

Other

Identifiers

NCT02255149
HUM00053796

Details and patient eligibility

About

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.

Full 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

Enrollment

10 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Bone/Mesh
Experimental group
Description:
Allograft and Titanium mesh will be used to grow jaw bone vertically.
Treatment:
Device: Bone/Mesh

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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