N/A
Completed N=144
Multicenter Retrospective Study Evaluating ATLANTIS™ Abutment Teeth Connected to Implants
Dental Implants
Source: ClinicalTrials.gov NCT02496091 ↗
Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Overall Success Rate — 240 Abutments
Summary
The study is designed as a retrospective and multi-center study. The study population is US individuals previously restored with titanium and gold-shaded titanium ATLANTIS abutments. The study includes retrospective data collection from the medical records and data collection from one prospective study visit with a clinical examination.The primary objective is to evaluate success. Success is defined as that the study implant and abutment are in situ and no Adverse Device Effects related to the study implant, abutment or adjacent peri-implant tissues are reported during the study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Success Rate |
240 | — |
| SECONDARY Study Position Implant and Abutment Survival |
256 | — |
| SECONDARY Presence of Plaque |
96 | — |
| SECONDARY Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD |
3.11 | — |
| SECONDARY Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP |
124 | — |
| SECONDARY Marginal Bone Level Change |
-0.30 | — |
Eligibility Criteria
Inclusion Criteria
- Having received one or more ATLANTIS abutments included in one or more permanent prosthetic restoration(s):
- during 2010, 2011, 2012 or 2013
- made of titanium or gold-shaded titanium
- connected to implants from: BIOMET 3i; Straumann; Nobel Biocare or DENTSPLY Implants (only ASTRA TECH Implant System).
- Being at least 18 years at day of enrollment
- Having signed and dated the informed consent form
Exclusion Criteria
- Unable to come for study visit
- Not willing to participate in the study or not able to understand the content of the study.
- Involvement in the planning and conduct of the study (applies to both DENTSPLY Implants staff and staff at the study site).
- Simultaneous participation in another clinical study that may interfere with the present study
Data sourced from ClinicalTrials.gov (NCT02496091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.