Clinical and Radiographic Outcomes of Dental Implant Therapy

NCT ID: NCT01825772

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

596 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peri-Implantitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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)
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Swedish Social Insurance Agency

OTHER_GOV

Sponsor Role collaborator

Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tord Berglundh, Professor

Role: STUDY_DIRECTOR

Göteborg University

Jan Derks, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Department of Periodontology, Institute of Odontology

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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Fransson C, Lekholm U, Jemt T, Berglundh T. Prevalence of subjects with progressive bone loss at implants. Clin Oral Implants Res. 2005 Aug;16(4):440-6. doi: 10.1111/j.1600-0501.2005.01137.x.

Reference Type BACKGROUND
PMID: 16117768 (View on PubMed)

Tomasi C, Derks J. Clinical research of peri-implant diseases--quality of reporting, case definitions and methods to study incidence, prevalence and risk factors of peri-implant diseases. J Clin Periodontol. 2012 Feb;39 Suppl 12:207-23. doi: 10.1111/j.1600-051X.2011.01831.x.

Reference Type BACKGROUND
PMID: 22533958 (View on PubMed)

Berglundh T, Persson L, Klinge B. A systematic review of the incidence of biological and technical complications in implant dentistry reported in prospective longitudinal studies of at least 5 years. J Clin Periodontol. 2002;29 Suppl 3:197-212; discussion 232-3. doi: 10.1034/j.1600-051x.29.s3.12.x.

Reference Type BACKGROUND
PMID: 12787220 (View on PubMed)

Derks J, Schaller D, Hakansson J, Wennstrom JL, Tomasi C, Berglundh T. Peri-implantitis - onset and pattern of progression. J Clin Periodontol. 2016 Apr;43(4):383-8. doi: 10.1111/jcpe.12535. Epub 2016 Mar 29.

Reference Type DERIVED
PMID: 26900869 (View on PubMed)

Derks J, Schaller D, Hakansson J, Wennstrom JL, Tomasi C, Berglundh T. Effectiveness of Implant Therapy Analyzed in a Swedish Population: Prevalence of Peri-implantitis. J Dent Res. 2016 Jan;95(1):43-9. doi: 10.1177/0022034515608832.

Reference Type DERIVED
PMID: 26701919 (View on PubMed)

Derks J, Hakansson J, Wennstrom JL, Tomasi C, Larsson M, Berglundh T. Effectiveness of implant therapy analyzed in a Swedish population: early and late implant loss. J Dent Res. 2015 Mar;94(3 Suppl):44S-51S. doi: 10.1177/0022034514563077. Epub 2014 Dec 11.

Reference Type DERIVED
PMID: 25503901 (View on PubMed)

Other Identifiers

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Jan1

Identifier Type: -

Identifier Source: org_study_id

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