An Open, Prospective, Multi-center Study to Evaluate the OsseoSpeed™ TX Implant With an Early Loading Protocol in Patients With Tooth Loss in the Posterior Maxilla. A 3-years Follow-up Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Partially Edentulous Jaw
- Sponsor
- Dentsply Sirona Implants and Consumables
- Enrollment
- 42
- Locations
- 3
- Primary Endpoint
- Marginal Bone Level Alteration
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX implants in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior maxilla up to 3 years after loading. Hypothesis: Early loading of the posterior maxilla is a safe and predictable procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Marginal Bone Level Alteration
Time Frame: Measured at implant loading and at the 3-year follow-up after implant loading.
Marginal bone level determined from radiographs and expressed as the distance from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal bone level expressed in millimeters at the 3-year follow-up visit compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
Secondary Outcomes
- Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD(Measured at the 3-year follow-up after implant loading.)
- Number of Survived Implants(Measured at the 3-year follow-up after implant loading.)
- Presence of Plaque(Measured at the 3-year follow-up after implant loading.)
- Number of Stable Implants(Measured at the 3-year follow-up after implant loading.)