Edentulous Jaw
Conditions
Brief summary
This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (\> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.
Detailed description
This study aims to enroll a total of 140 patients (140 implants) who are in need of treatment with dental implants in one or more edentulous areas of the maxilla and/or mandible. Approximately 4 sites will be participating, each one contributing 35 patients to the study dataset. The main objectives of this study will be: 1. The integration success of the dental implant (as measured by mobility) 2. The measured changes in peri-implant crestal bone levels for each implant 3. Confirmation of clinical benefits
Interventions
DEVICET3 dental implant system
This clinical study will evaluate patients being treated with the T3 dental implant to confirm its safety and performance (effect of treatment of edentulism). The patients treated will experience a benefit from treatment of edentulism with the T3 dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years).
Sponsors
ZimVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients of either sex and at least 18 years of age. 2. Patients for whom a decision has already been made to use a dental implant for the restoration of existing edentulism in the mandible and/or maxilla. 3. Prior extracted sites or simultaneous extraction/implant placement. 4. Patients must be physically able to tolerate conventional surgical and restorative procedures. 5. Patients who provide a signed informed consent. 6. Patients who agree to be evaluated for each study visit.
Exclusion criteria
1. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment. 2. Patients who have previously failed dental implants at the site intended for study implant placement. 3. Patients with active HIV or Hepatitis infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental implant integration | 2 years | The integration success measured by lack of mobility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crestal Bone Loss | 2 years | The measured changes in peri-implant crestal bone levels |
Countries
Germany, United States
Contacts
STUDY_DIRECTORHai Bo Wen, PhD
ZimVie
Outcome results
None listed