Partial Edentulism, Tooth Disease
Conditions
Keywords
edentulism, dental implants, clinical study, endosseous, randomized, crestal bone level, T3, Nanotite Certain, Nanotite Certain Prevail, Tapered
Brief summary
This study evaluates the T3 implant system for the preservation of alveolar crestal bone and the establishment of initial integration. The new surface-treated features of the implant may contribute to improved soft and hard tissue healing. The success rate of the T3 implant will be no different than that of the control implant, which possess similar geometry but different surface treatments.
Detailed description
This prospective, randomized-controlled study will enroll qualified patients with partial edentulism who will be treated with at least two dental implants. Implant sites will be randomly assigned to receive either a test (T3 implant) or control (Nanotite Certain Tapered implant) with an 80:20 (test:control) randomization ratio. All implants will be allowed to integrate without occlusal forces and final restorations will be cemented thereafter. Cumulative success rate and crestal bone regression of both treatment groups will be the primary and secondary study endpoints, respectively.
Interventions
DEVICET3 with DCD tapered Prevail implant
T3 with DCD implant with Certain (internal) connection and platform-switch design
Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design
Sponsors
ZimVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of either sex and any race greater than 18 years of age * Patients for whom a decision has already been made to use dental implants for the restoration of existing edentulism in the mandible or maxilla. * Patients must be physically able to tolerate conventional surgical and restorative procedures. * Patients must agree to be evaluated for each study visit, especially the yearly follow-up visits
Exclusion criteria
* Patients with active infection or severe inflammation in the areas intended for implant placement. * Patients with a \> 10 cigarette per day smoking habit. * Patients with uncontrolled diabetes mellitus. * Patients with uncontrolled metabolic bone disease where there is a diagnosis of the following: Osteomalacia, primary or secondary hyperparathyroidism, renal osteodystrophy, or Paget's disease of bone. * Patients with a history of therapeutic radiation to the head * Patients in need of bone grafting at the site of the intended study implant for augmentation purposes. * Patients who are known to be pregnant at the screening visit. * Patients with evidence of severe para-functional habits such as bruxing or clenching.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Success Rate | 1 year | Implant mobility is assessed by clinical evaluations and correlation to initial placement stability- insertion torque profiles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crestal Bone Changes | 2 years | Crestal bone regression (amount of bone loss) between the two treatment groups will be compared |
Countries
Belgium, France, Germany, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORNicholas Lewis, DMD
Eastman Dental Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 8 |
| other Total, other adverse events | 6 / 32 | 4 / 8 |
| serious Total, serious adverse events | 0 / 32 | 0 / 8 |
Outcome results
None listed