A Prospective Analysis of Failures of Oral Implants
Study Details
Study Description
Brief Summary
The purpose of this prospective clinical trial is to investigate and identify factors associated with the failure of dental implants within the population rehabilitated with dental implants at the Folktandvården Specialistklinik in Malmö (Spårvägsgatan 12, 214 27, Malmö).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The treatment begins with screening against inclusion and exclusion criteria. The patients will then be informed of the design of the study through the reading of the Form for Patient Information and the Informed Consent in Swedish and verbally.
All dental implants to be inserted will be included in the study. Some surgical, implant, loading, prosthetic variables of the study will be decided according to the surgeon's criteria and patient's decisions.
Data will be collected in specific forms, and will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and complications.
Besides descriptive statistics, Kaplan-Meier analysis will be used to estimate implant survival/failure rates (an estimator for estimating the survival function from lifetime data), and multivariate Cox proportional hazards models will be used to identify prognostic variables.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Dental implants Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 and August 31st 2017 |
Procedure: Insertion of dental implants
Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 to August 31st 2017
Other Names:
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Outcome Measures
Primary Outcome Measures
- Survival of implants [Up to 3 years]
Time from the surgical placement of implants until the last follow-up visit or until its failure
Secondary Outcome Measures
- Marginal bone loss [Up to 3 years]
Time from the surgical placement of implants until the last follow-up visit
- Dental prosthesis complications [Up to 3 years]
Time from the surgical placement of implants until the last follow-up visit
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with a minimum age of 18 years;
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Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.
Exclusion Criteria:
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Age less than 18 years;
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General contraindications for implant surgery;
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Subjects with an untreated systemic disease. A complete medical report will permit the disqualification of subjects with an untreated systemic disease. Patients with a systemic disease such as diabetes or hypertension will not be excluded, as long as these pathologies were treated and stabilized within normal biologic parameters.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Folktandvården Specialistklinik | Malmö | Skåne | Sweden | 214 27 |
Sponsors and Collaborators
- Malmö University
- Region Skane
Investigators
- Principal Investigator: Bruno R Chrcanovic, DDS MSc, Malmö University
- Study Chair: Ann Wennerberg, DDS PhD, Malmö University
- Study Chair: Tomas Albrektsson, MD PhD, Göteborg University / Malmö University
- Study Director: Jenö Kisch, DDS, Region Skåne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Dnr 2014/333