A Retrospective Analysis of Failures of Oral Implants

A Retrospective Analysis of Failures/Complications With 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).

Study Overview

• Status: Completed
• Conditions: Periodontal Bone Loss; Dental Implant Failure
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 2670

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Malmö, Skåne, Sweden, 214 27
      • Folktandvården Specialistklinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The population rehabilitated with dental implants at/or referred to prosthetic rehabilitation at the Avdelning för Oral Protetik at the Folktandvården Specialistklinik in Malmö.

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?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of implants	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 from the surgical placement of implants until the last follow-up	Including implants placed from 1980 until August 31st 2014

Collaborators and Investigators

• Sponsor: Malmö University
• Collaborators: Region Skane
• 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

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 17, 2015
• First Posted (Estimated): February 24, 2015

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Dental implants; Periodontal Bone Loss
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: Dnr 2014/598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO