Partial Edentulism, Tooth Disease
Conditions
Keywords
dental implants, Nanotite implant, Osseotite implants, multicenter, randomized, clinical study, partial edentulism, prosthesis
Brief summary
This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.
Detailed description
This multicenter, prospective, randomized-controlled study will compare the performance of the Nanotite vs. the standard Ossotite implants when placed by graduate students with little or no prior experience. Enrolled patients will have the study site(s) randomized to either a Nanotite (test) or an Osseotite (control) implant. The manner of treatment observed at the participating center will be followed for this study. Study Hypothesis: The performance of the Nanotite implant in this study will be no different than or superior to that of the Osseotite implant placed during the early period of graduate student training.
Interventions
DEVICENanotite dental implant
Nanotite root form titanium dental implant
DEVICEOsseotite dental implant
Osseotite Root form titanium dental implant
Sponsors
ZimVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
implant types were randomized- 2 different surface treatments
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients of either sex and of any race, 18 years of age or older * patients for whom a decision has already been made to use dental implants for treating edentulism in the mandible or maxilla
Exclusion criteria
* patients who are known to be pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Integration Success of the Implant | 1 year |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael S Reddy, DMD
University of Alabama at Birmingham
Participant flow
Recruitment details
Up to 165 patients are expected to be enrolled across all centers, with enrollment efforts beginning in August 2008. Enrollment period remained opent until December 2010.
Pre-assignment details
Pre-treatment included a screening visit (enroll those meeting all protocol inclusion criteria), signing informed consent, and pre-surgical data collection. Patients returned for implant placement surgery, followed by restorative activities.
Participants by arm
| Arm | Count |
|---|---|
| Nanotite Implant Nanotite dental implant
Nanotite dental implant : Nanotite root form titanium dental implant | 122 |
| Osseotite Implant Osseotite dental implant
Osseotite dental implant : Osseotite Root form titanium dental implant | 119 |
| Total | 241 |
Baseline characteristics
| Characteristic | Nanotite Implant | Osseotite Implant | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 60 Participants | 56 Participants | 116 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 63 Participants | 124 Participants |
| Sex: Female, Male Female | 61 Participants | 64 Participants | 125 Participants |
| Sex: Female, Male Male | 61 Participants | 55 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 9 / 122 | 7 / 119 |
| serious Total, serious adverse events | 0 / 122 | 0 / 119 |
Outcome results
Primary
Integration Success of the Implant
Time frame: 1 year
Population: Number of implants surviving (lack of mobility) at the end of the study (time of analysis)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nanotite Implant | Integration Success of the Implant | 230 implants |
| Osseotite Implant | Integration Success of the Implant | 239 implants |