A Prospective Analysis of Failures of Oral Implants

Not Applicable

Completed

• Conditions: Periodontal Bone Loss; Dental Implant Failure
• Interventions: Procedure: Insertion of dental implants

• Registration Number: NCT02374216
• Lead Sponsor: Malmö University

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-23
• Study First Posted: 2015-02-27
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dental implants	Insertion of dental implants	Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 and August 31st 2017

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Dental prosthesis complications	Up to 3 years	Time from the surgical placement of implants until the last follow-up visit
Marginal bone loss	Up to 3 years	Time from the surgical placement of implants until the last follow-up visit

Trial Locations

Locations (1)

Folktandvården Specialistklinik; 🇸🇪 Malmö, Skåne, Sweden