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A Prospective Analysis of Failures of Oral Implants

Primary Purpose

Dental Implant Failure, Periodontal Bone Loss

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Insertion of dental implants

About this trial

This is an interventional diagnostic trial for Dental Implant Failure focused on measuring Dental Implants, Periodontal Bone Loss, Implant-Supported Dental Prosthesis, Dental Prosthesis Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

Folktandvården Specialistklinik

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dental implants

Arm Description

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

Outcomes

Primary Outcome Measures

Survival of implants

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

Secondary Outcome Measures

Marginal bone loss

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

Dental prosthesis complications

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

Full Information

NCT ID

NCT02374216

First Posted

February 10, 2015

Last Updated

March 5, 2019

Sponsor

Malmö University

Collaborators

Region Skane

1. Study Identification

Unique Protocol Identification Number

NCT02374216

Brief Title

A Prospective Analysis of Failures of Oral Implants

Official Title

A Prospective Analysis of Failures/Complications With Oral Implants

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

August 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Malmö University

Collaborators

Region Skane

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Implant Failure, Periodontal Bone Loss

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dental implants

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Insertion of dental implants

Other Intervention Name(s)

Dental implant surgical placement

Intervention Description

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

Primary Outcome Measure Information:

Title

Survival of implants

Description

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

Time Frame

Up to 3 years

Secondary Outcome Measure Information:

Title

Marginal bone loss

Description

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

Time Frame

Up to 3 years

Title

Dental prosthesis complications

Description

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

Time Frame

Up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruno R Chrcanovic, DDS MSc

Organizational Affiliation

Malmö University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ann Wennerberg, DDS PhD

Organizational Affiliation

Malmö University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tomas Albrektsson, MD PhD

Organizational Affiliation

Göteborg University / Malmö University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jenö Kisch, DDS

Organizational Affiliation

Region Skåne

Official's Role

Study Director

Facility Information:

Facility Name

Folktandvården Specialistklinik

City

Malmö

State/Province

Skåne

ZIP/Postal Code

214 27

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

A Prospective Analysis of Failures of Oral Implants

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