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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02374216
Other study ID # Dnr 2014/333
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2014
Est. completion date August 2018

Study information

Verified date March 2019
Source Malmö University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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

Locations

Country Name City State
Sweden Folktandvården Specialistklinik Malmö Skåne

Sponsors (2)

Lead Sponsor Collaborator
Malmö University Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival of implants Time from the surgical placement of implants until the last follow-up visit or until its failure Up to 3 years
Secondary Marginal bone loss Time from the surgical placement of implants until the last follow-up visit Up to 3 years
Secondary Dental prosthesis complications Time from the surgical placement of implants until the last follow-up visit Up to 3 years
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