Clinical and Radiographic Outcomes of Dental Implant Therapy

March 16, 2022 updated by: Göteborg University

900 subjects having received dental implants 9-10 years ago are invited for a clinical and radiographic examination. The individuals were randomly selected from the National Health Insurance data register in Sweden.

The clinical and radiographic examination of the 900 selected subjects will include assessments of implant loss, loss of prosthesis and technical / biological complications.

Biological complications will be assessed from the findings in the clinical and radiographic examinations. Thus, signs of pathology in peri-implant tissues, probing pocket depth (PPD) and bleeding/pus on probing (BoP) will be recorded. Marginal bone loss and other findings in radiographs will also be evaluated.

The prevalence, extent and severity of peri-implantitis will hereby be determined. Patient-centered outcomes will also be obtained.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

596

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 40530
        • Department of Periodontology, Institute of Odontology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The register of the Swedish Social Insurance Agency was searched for subjects scheduled for treatment with dental implants in 2003/2004. In a first group, subjects between 65 and 75 years old in 2003 were identified and from this pool of about 23.000 individuals, 3.000 subjects were randomly selected. In a second group, all subjects in the age of 45-60 years were identified (n=1716)from the same register. Thus, the total study population in the present project included 4716 subjects.

Description

A questionnaire was distributed to the 4716 identified subjects. 3827 questionnaires (81.15%) were returned and, hence, included in the analysis.

From the sample of 3827 patients who responded to the questionnaire, 3107 (81.19%) gave their consent for access of patient files/records.

Patient files/records of 2780 individuals could be collected from the treating dentists (89.48%). Out of the 2780, 900 individuals were selected by random sampling, stratifying only for the two age groups.

Inclusion Criteria:

  • Having received implants within the Swedish insurance system in 2003/2004.
  • Being in one of the two age groups in 2003: 65-75 years and 45 - 55 years.
  • Having answered the initial questionnaire
  • Treating dentist provided patient files/records

Exclusion Criteria:

- Having died during the study period (collection of questionnaire and patient files/records)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-implantitis
Time Frame: 9-10 years following implant installation
All subjects were provided with dental implants in 2003/2004. The clinical and radiographic examinations will be carried out in 2013.
9-10 years following implant installation

Secondary Outcome Measures

Outcome Measure
Time Frame
Implant loss
Time Frame: 9-10 years after having received dental implants
9-10 years after having received dental implants

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical complications
Time Frame: 9-10 years after receiving dental implants
Technical complications relating to implant components or the prosthetic reconstruction are recorded. Recorded complications are (i) acrylic/porcelain fractures, (ii) screw-loosening and decementation, (iii) abutment screw loosening or fractures and (i) implant fractures.
9-10 years after receiving dental implants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

The Swedish Research Council
Swedish Social Insurance Agency

Investigators

  • Study Director: Tord Berglundh, Professor, Göteborg University
  • Principal Investigator: Jan Derks, PhD Student, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 3, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jan1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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