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OpenTrials
Completed

NCT Number: NCT01825772

Clinical and Radiographic Outcomes of Dental Implant Therapy

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Periodontology, Institute of Odontology

Gothenburg, 40530, Sweden

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Implant loss

    Time frame: 9-10 years after having received dental implants

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Swedish Social Insurance Agency
  • The Swedish Research Council

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2013
Registry last updated
Mar 31, 2022

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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