A Prospective Analysis of Failures of Oral Implants

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Analysis of Failures/Complications With Oral Implants

Conditions
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Dental Implant Failure, Periodontal Bone Loss

Intervention / Treatment
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* Procedure: Insertion of dental implants


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dental implants<br>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<br>* Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 to August 31st 2017<br>* Other names: Dental implant surgical placement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of implants | Time from the surgical placement of implants until the last follow-up visit or until its failure | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Marginal bone loss | Time from the surgical placement of implants until the last follow-up visit | Up to 3 years | 
| Dental prosthesis complications | Time from the surgical placement of implants until the last follow-up visit | Up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implants, Periodontal Bone Loss, Implant-Supported Dental Prosthesis, Dental Prosthesis Failure