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A Prospective Analysis of Failures of Oral Implants

M

Malmö University

Status

Completed

Conditions

Dental Implant Failure
Periodontal Bone Loss

Treatments

Procedure: Insertion of dental implants

Study type

Interventional

Funder types

Other

Identifiers

NCT02374216
Dnr 2014/333

Details and patient eligibility

About

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).

Full 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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

Dental implants
Other group
Description:
Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 and August 31st 2017
Treatment:
Procedure: Insertion of dental implants

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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