Alveolar Bone Loss
Conditions
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
Interventions
DEVICEBone/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.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Height | 5 months | Diameter of the bone measured from the alveolar crest to the inferior alveolar nerve after the grafting procedures from CBCT images. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bone/Mesh Allograft and Titanium mesh will be used to grow jaw bone vertically.
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. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Implant Failure | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by PI | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Bone/Mesh |
|---|---|
| Age, Customized >=18 | 9 years |
| Bone height | 9.8 millimeters |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Bone Height
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bone/Mesh | Bone Height | 12.2 millimeters |