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Completed

NCT Number: NCT02369562

A Retrospective Analysis of Failures of Oral Implants

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).

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Folktandvården Specialistklinik

Malmö, Skåne County, 214 27, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evaluation of the failure rate of dental implants

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

Other names: Implant failure rate assessment

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Collaborators

  • Region Skane

Registry information

Official study title

A Retrospective Analysis of Failures/Complications With Oral Implants

Important dates

Study start
2014
Primary completion
2015
Study completion
2018
First posted
Feb 24, 2015
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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