N/A
Completed N=208
Retrospective Evaluation of Clinical Performance of the Astra Tech Implant System EV When Used in Everyday Practice
Dental Implants
Source: ClinicalTrials.gov NCT03845738 ↗
Enrolled (actual)
208
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Percent of Survived Implants at Time of the Follow-up Visit — 3; 382; 0 Implants
Summary
This study is designed as a retrospective, multi-center study. The study population consist of subjects who received one or more OsseoSpeed EV implants during the period January 1st 2015 to December 31st 2016. Two hundred subjects will be enrolled, approximately 25-30 subjects per site. The study includes retrospective data collection from subjects' medical records and data collection from one prospective study visit with a clinical examination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Survived Implants at Time of the Follow-up Visit |
3; 382; 0 | — |
| SECONDARY Percent of Successful Implants at Time of the Follow-up Visit |
7; 378; 0 | — |
| SECONDARY Percent of Successful Prosthetics at Time of the Follow-up Visit |
30; 354; 1 | — |
| SECONDARY Marginal Bone Levels (MBL) |
0.2; 0.3; 0.3; 0.4; 0.28; 0.38 | — |
| SECONDARY Soft Tissue Response Measured Through Probing Pocket Depth (PPD) at Time of Follow-up Visit |
2.7 | — |
| SECONDARY Soft Tissue Response Measured Through Bleeding on Probing (BoP) at Time of Follow-up Visit |
90 | — |
| SECONDARY Soft Tissue Response Measured Through Presence of Plaque at Time of Follow-up Visit |
63 | — |
| SECONDARY Patient Reported Outcome on Implant Level at Time of Follow-up Visit |
4.7; 4.7; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Subject ≥ 18 years at time of implant installation.
- Subject signed and dated the informed consent form.
- Having installed one or more OsseoSpeed EV implants between January 1st 2015 and December 31st 2016.
Exclusion Criteria
- Unlikely to be able to comply with study procedures, according to Investigator's judgement.
- Subject is not willing to participate in the study or not able to understand the content of the study.
- Involvement in the planning or conduct of the study.
- Simultaneous participation in another clinical study that may interfere with the present study.
- Severe non-compliance to Clinical Investigation Plan (CIP) as judged by the Investigator and/or Dentsply Sirona Implants.
Data sourced from ClinicalTrials.gov (NCT03845738). 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.