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Completed

NCT Number: NCT02374216

A Prospective Analysis of Failures of 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Folktandvården Specialistklinik

Malmö, Skåne County, 214 27, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insertion of dental implants

Procedure

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

Primary outcomes

  1. 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

  1. Marginal bone loss

    Time frame: Up to 3 years

    Time from the surgical placement of implants until the last follow-up visit

  2. Dental prosthesis complications

    Time frame: Up to 3 years

    Time from the surgical placement of implants until the last follow-up visit

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Collaborators

  • Region Skane

Registry information

Official study title

A Prospective Analysis of Failures/Complications With Oral Implants

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2015
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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