A Prospective Analysis of Failures of Oral Implants

March 5, 2019 updated by: Bruno Ramos Chrcanovic, Malmö University

A Prospective Analysis of Failures/Complications With Oral Implants

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Malmö, Skåne, Sweden, 214 27
        • Folktandvården Specialistklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Dental implant surgical placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Malmö University

Collaborators

Region Skane

Investigators

  • Study Chair: Ann Wennerberg, DDS PhD, Malmö University
  • Study Chair: Tomas Albrektsson, MD PhD, Göteborg University / Malmö University
  • Study Director: Jenö Kisch, DDS, Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 23, 2015

First Posted (Estimate)

February 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnr 2014/333

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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