A Prospective Analysis of Failures of Oral Implants

NCT ID: NCT02374216

Last Updated: 2019-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-08-31

Brief Summary

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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

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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.

Conditions

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Dental Implant Failure Periodontal Bone Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dental implants

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

Group Type OTHER

Insertion of dental implants

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Dental implant surgical placement

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Region Skane

OTHER

Sponsor Role collaborator

Malmö University

OTHER

Sponsor Role lead

Responsible Party

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Bruno Ramos Chrcanovic

DDS, MSc, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno R Chrcanovic, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

Malmö University

Ann Wennerberg, DDS PhD

Role: STUDY_CHAIR

Malmö University

Tomas Albrektsson, MD PhD

Role: STUDY_CHAIR

Göteborg University / Malmö University

Jenö Kisch, DDS

Role: STUDY_DIRECTOR

Region Skåne

Locations

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Folktandvården Specialistklinik

Malmo, Skåne County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Dnr 2014/333

Identifier Type: -

Identifier Source: org_study_id

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