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A Prospective Analysis of Failures of Oral Implants

A Prospective Analysis of Failures/Complications With Oral Implants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02374216
Enrollment
200
Registered
2015-02-27
Start date
2014-09-30
Completion date
2018-08-31
Last updated
2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant Failure, Periodontal Bone Loss

Keywords

Dental Implants, Periodontal Bone Loss, Implant-Supported Dental Prosthesis, Dental Prosthesis Failure

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.

Interventions

Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 to August 31st 2017

Sponsors

Region Skane
CollaboratorOTHER
Malmö University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Survival of implantsUp to 3 yearsTime from the surgical placement of implants until the last follow-up visit or until its failure

Secondary

MeasureTime frameDescription
Marginal bone lossUp to 3 yearsTime from the surgical placement of implants until the last follow-up visit
Dental prosthesis complicationsUp to 3 yearsTime from the surgical placement of implants until the last follow-up visit

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026