A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw
Primary Purpose
Alveolar Bone Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bone/Mesh
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bone/Mesh
Arm Description
Allograft and Titanium mesh will be used to grow jaw bone vertically.
Outcomes
Primary Outcome Measures
Bone Height
Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.
Secondary Outcome Measures
Full Information
NCT ID
NCT02255149
First Posted
September 29, 2014
Last Updated
January 27, 2017
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT02255149
Brief Title
A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw
Official Title
Vertical Ridge Augmentation Using Titanium Mesh and Allograft in Posterior Mandible: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bone/Mesh
Arm Type
Experimental
Arm Description
Allograft and Titanium mesh will be used to grow jaw bone vertically.
Intervention Type
Device
Intervention Name(s)
Bone/Mesh
Intervention Description
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 Outcome Measure Information:
Title
Bone Height
Description
Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsun-Liang Chan, DDS, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26133141
Citation
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.
Results Reference
result
Learn more about this trial
A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw
We'll reach out to this number within 24 hrs