A Retrospective Analysis of Failures of Oral Implants

Periodontal Bone Loss Clinical Trial

Official title:

A Retrospective Analysis of Failures/Complications With Oral Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02369562
• Other study ID #: Dnr 2014/598
• Status: Completed
• Start date: September 2014
• Est. completion date: September 2018

Study information

• Verified date: October 2023
• Source: Malmö University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2670
• Est. completion date: September 2018
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Dental Implant Failure
• Periodontal Bone Loss

Intervention

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

Locations

Country	Name	City	State
Sweden	Folktandvården Specialistklinik	Malmö	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Malmö University	Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Marginal bone loss	Time from the surgical placement of implants until the last follow-up	Including implants placed from 1980 until August 31st 2014