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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bone/Mesh

Device

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.

Primary outcomes

Bone Height

Time frame: 5 months

Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Oct 2, 2014
Registry last updated: Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed