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

NCT ID: NCT02255149

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-11-30

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

Conditions

Alveolar Bone Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bone/Mesh

Allograft and Titanium mesh will be used to grow jaw bone vertically.

Group Type: EXPERIMENTAL

Bone/Mesh

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Hsun-Liang Chan

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsun-Liang Chan, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

References

Chan HL, Benavides E, Tsai CY, Wang HL. A Titanium Mesh and Particulate Allograft for Vertical Ridge Augmentation in the Posterior Mandible: A Pilot Study. Int J Periodontics Restorative Dent. 2015 Jul-Aug;35(4):515-22. doi: 10.11607/prd.1980.

Reference Type: RESULT

PMID: 26133141 (View on PubMed)

Other Identifiers

HUM00053796

Identifier Type: -

Identifier Source: org_study_id