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

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ClinicalTrials.gov Identifier: NCT02255149
Recruitment Status : Completed
First Posted : October 2, 2014
Results First Posted : April 19, 2016
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Hsun-Liang Chan, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Alveolar Bone Loss Device: Bone/Mesh Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vertical Ridge Augmentation Using Titanium Mesh and Allograft in Posterior Mandible: A Feasibility Study
Study Start Date : September 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
Experimental: Bone/Mesh
Allograft and Titanium mesh will be used to grow jaw bone vertically.
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.




Primary Outcome Measures :
  1. Bone Height [ Time Frame: 5 months ]
    Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255149


Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Hsun-Liang Chan, DDS, MS University of Michigan
Publications of Results:
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Responsible Party: Hsun-Liang Chan, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02255149    
Other Study ID Numbers: HUM00053796
First Posted: October 2, 2014    Key Record Dates
Results First Posted: April 19, 2016
Last Update Posted: March 10, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases