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A Retrospective Analysis of Failures of Oral Implants

Sponsor
Malmö University (Other)
Overall Status
Completed
CT.gov ID
NCT02369562
Collaborator
Region Skane (Other)
2,670
Enrollment
1
Location
48
Duration (Months)
55.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this retrospective study 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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Evaluation of the failure rate of dental implants

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 Design

Study Type:
Observational
Actual Enrollment :
2670 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Retrospective Analysis of Failures/Complications With Oral Implants
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Dental implant patients

All patients rehabilitated with dental implants.

Procedure: Evaluation of the failure rate of 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:
  • Implant failure rate assessment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Survival of implants [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

    Secondary Outcome Measures

    1. Marginal bone loss [Including implants placed from 1980 until August 31st 2014]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Folktandvården Specialistklinik Malmö Skåne Sweden 214 27

    Sponsors and Collaborators

    • Malmö University
    • Region Skane

    Investigators

    • Principal Investigator: Bruno R Chrcanovic, DDS MSc, Malmö University
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bruno Ramos Chrcanovic, DDS, MSc, PhD student, Malmö University
    ClinicalTrials.gov Identifier:
    NCT02369562
    Other Study ID Numbers:
    • Dnr 2014/598
    First Posted:
    Feb 24, 2015
    Last Update Posted:
    Mar 6, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Bruno Ramos Chrcanovic, DDS, MSc, PhD student, Malmö University
    Dental implants
    Periodontal Bone Loss
    Additional relevant MeSH terms:
    Alveolar Bone Loss

    Study Results

    No Results Posted as of Mar 6, 2019