A Prospective Analysis of Failures/Complications With Oral Implants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implant Failure
- Sponsor
- Malmö University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Survival of implants
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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).
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.
Investigators
Bruno Ramos Chrcanovic
DDS, MSc, PhD student
Malmö University
Eligibility Criteria
Inclusion Criteria
- •Patients with a minimum age of 18 years;
- •Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.
Exclusion Criteria
- •Age less than 18 years;
- •General contraindications for implant surgery;
- •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.
Outcomes
Primary Outcomes
Survival of implants
Time Frame: Up to 3 years
Time from the surgical placement of implants until the last follow-up visit or until its failure
Secondary Outcomes
- Dental prosthesis complications(Up to 3 years)
- Marginal bone loss(Up to 3 years)