Alveolar Bone LossNCT02255149
A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw
A study testing Bone/Mesh in people with Alveolar Bone Loss, run by University of Michigan.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Bone/Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
About this study
Official title: Vertical Ridge Augmentation Using Titanium Mesh and Allograft in Posterior Mandible: A Feasibility Study
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.
Read the 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
- Conditions
- Alveolar Bone Loss
- Being tested
- Bone/Mesh
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone/MeshDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bone/Mesh | Experimental | Allograft and Titanium mesh will be used to grow jaw bone vertically. Receives: Device: Bone/Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Height
Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startSep 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsun-Liang Chan, University of Michigan
- Investigators
- Hsun-Liang Chan, DDS, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255149
- Sponsor's protocol ID
- HUM00053796
- Status last verified
- Nov 2023
- First submitted
- 29 Sep 2014
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26133141
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vertical Ridge Augmentation Using Titanium Mesh and Allograft in Posterior Mandible: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02255149
- Acronym / sponsor ID
- HUM00053796
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Posted 19 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bone/Mesh | Experimental | Device: Bone/MeshAllograft and Titanium mesh will be used to grow jaw bone vertically. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone/MeshA 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. | Device | Bone/Mesh |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26133141Chan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsun-Liang Chan, DDS, MS principal investigator
University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing Bone/Mesh in people with Alveolar Bone Loss, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Height (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02255149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.