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

November 2, 2023 updated by: Hsun-Liang Chan, University of Michigan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bone/Mesh
Allograft and Titanium mesh will be used to grow jaw bone vertically.
Device: Bone/Mesh
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Hsun-Liang Chan, DDS, MS, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimated)

October 2, 2014

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00053796

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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