A Retrospective Analysis of Failures of Oral Implants

NCT ID: NCT02369562

Last Updated: 2023-10-19

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

Total Enrollment

2670 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-09-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Dental Implant Failure Periodontal Bone Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dental implant patients

All patients rehabilitated with dental implants.

Evaluation of the failure rate of dental implants

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Implant failure rate assessment

Eligibility Criteria

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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.
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_DIRECTOR

Malmö University

Tomas Albrektsson, MD PhD

Role: STUDY_DIRECTOR

Göteborg University / Malmö University

Jenö Kisch, DDS

Role: STUDY_CHAIR

Region Skane

Locations

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Folktandvården Specialistklinik

Malmo, Skåne County, Sweden

Site Status

Countries

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Sweden

References

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Chrcanovic BR, Kisch J, Albrektsson T, Wennerberg A. Factors Influencing Early Dental Implant Failures. J Dent Res. 2016 Aug;95(9):995-1002. doi: 10.1177/0022034516646098. Epub 2016 May 4.

Reference Type DERIVED
PMID: 27146701 (View on PubMed)

Other Identifiers

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Dnr 2014/598

Identifier Type: -

Identifier Source: org_study_id

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