Clinical trial NCT02255149: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-10-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Bone Height
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Hsun-Liang Chan, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.