A Retrospective Analysis of Failures of Oral Implants
A Retrospective Analysis of Failures/Complications With Oral Implants
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a retrospective study that involves collecting information about the past and comparing that with contemporary information collected from the same cases. The patients' dental records' archive and the digital dental records of the Folktandvården Specialistklinik in Malmö will be scrutinized. The patients will be retraced in the Swedish Personal Data System and will be invited for a recall visit with a clinical and radiographic examination. 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. In case the patient is not willing to pay a recall visit, only the data of the patient's records will be used, under the patients' approval.
The data from the patients' records will be directly inserted to a computer file of the statistical software Statistical Package for the Social Sciences (SPSS Inc., Chicago, USA). The additional follow-up information from the patients' recall visit will be collected in specific forms and then inserted to the previously mentioned computer file. All dental implants inserted will be included in the study. Data will be categorized as surgical, implant-specific, patient-related, anatomic, loading conditions, prosthetic, and trans- and postoperative complications.
Periapical radiographies of the patients' digital record will be neatly filed in a computer file. Periapical radiographies that could possibly exist in celluloid film will be digitalized. From each patient, additional radiographs will be selected from the patient's record, based on availability in several time intervals. At the recall consultation, new periapical radiographies will be taken. The reference point will be established at the implants-abutment junction, and the marginal bone level measurement will be performed by using the Image J software.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Skåne
-
Malmö, Skåne, Sweden, 214 27
- Folktandvården Specialistklinik
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All treated patients with dental implants placed and restored at the Avdelning för Oral Protetik at the Folktandvården Specialistklinik in Malmö with an available dental record;
- Patients having read, understood, and signed the Form for Patient Information and the Informed Consent.
Exclusion Criteria:
- Patients not willing to give their permission to scrutinize their records;
- Lack of enough data in the patients' dental records.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Dental implant patients
All patients rehabilitated with dental implants.
|
Evaluation of the failure rate of dental implants, from the time of implant insertion (any time between 1980 and August 31st 2014) until September 2015
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival of implants
Time Frame: Including implants placed from 1980 until August 31st 2014
|
Time from the surgical placement of implants until the last follow-up or until its failure
|
Including implants placed from 1980 until August 31st 2014
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marginal bone loss
Time Frame: Including implants placed from 1980 until August 31st 2014
|
Time from the surgical placement of implants until the last follow-up
|
Including implants placed from 1980 until August 31st 2014
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ann Wennerberg, DDS PhD, Malmö University
- Study Director: Tomas Albrektsson, MD PhD, Göteborg University / Malmö University
- Study Chair: Jenö Kisch, DDS, Region Skane
- Principal Investigator: Bruno R Chrcanovic, DDS MSc, Malmö University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 2014/598
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.