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
Sponsored by
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
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
No
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
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
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A Prospective Analysis of Failures of Oral Implants
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