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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
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 29, 2014
    Last Updated
    January 27, 2017
    Sponsor
    University of Michigan
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    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

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

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