Clinical and Radiographic Outcomes of Dental Implant Therapy

NCT01825772 | Completed

• 1 other identifier: Jan1
• Study Type: observational
• Target: 596
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-Implantitis

Keywords

Cross-Sectional Studies; Prevalence; Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Peri-implantitis

  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 Outcomes (1)

• Implant loss

  9-10 years after having received dental implants

Other Outcomes (1)

• Technical complications

  9-10 years after receiving dental implants

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead
• The Swedish Research Council: collaborator
• Swedish Social Insurance Agency: collaborator

Study Sites (1)

Department of Periodontology, Institute of Odontology

Gothenburg, 40530, Sweden

Location

Related Publications (6)

• 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.

  PMID: 16117768 BACKGROUND

• 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.

  PMID: 22533958 BACKGROUND

• 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.

  PMID: 12787220 BACKGROUND

• 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.

  PMID: 26900869 DERIVED

• 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.

  PMID: 26701919 DERIVED

• 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.

  PMID: 25503901 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Tord Berglundh, Professor

  Göteborg University

  STUDY DIRECTOR

• Jan Derks, PhD Student

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 8, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

SE (1)