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

NCT02255149 | Completed Results DMC

• 1 other identifier: HUM00053796
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (1)

• Bone Height

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

  5 months

Study Arms (1)

Bone/Mesh

EXPERIMENTAL

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

Device: Bone/Mesh

Interventions

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.

Bone/Mesh

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Related Publications (1)

• 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.

  PMID: 26133141 RESULT

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Hsun-Liang Chan
• Organization: University of Michigan

hlchan@umich.edu

734-763-3325

Study Officials

• Hsun-Liang Chan, DDS, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 2, 2014
• Study Start: September 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 21, 2023
• Results First Posted: April 19, 2016

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share