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

Alveolar Bone Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255149
• Other study ID #: HUM00053796
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: November 2014

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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