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Clinical and Radiographic Outcomes of Dental Implant Therapy

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ClinicalTrials.gov Identifier: NCT01825772
Recruitment Status : Completed
First Posted : April 8, 2013
Last Update Posted : February 4, 2014
Sponsor:
Collaborators:
The Swedish Research Council
Swedish Social Insurance Agency
Information provided by (Responsible Party):
Göteborg University

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.


Condition or disease
Peri-Implantitis

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Study Type : Observational
Actual Enrollment : 596 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical and Radiographic Outcomes of Dental Implant Therapy
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014



Primary Outcome Measures :
  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 Outcome Measures :
  1. Implant loss [ Time Frame: 9-10 years after having received dental implants ]

Other Outcome Measures:
  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.



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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825772


Locations
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Sweden
Department of Periodontology, Institute of Odontology
Gothenburg, Sweden, 40530
Sponsors and Collaborators
Göteborg University
The Swedish Research Council
Swedish Social Insurance Agency
Investigators
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Study Director: Tord Berglundh, Professor Göteborg University
Principal Investigator: Jan Derks, PhD Student Göteborg University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT01825772     History of Changes
Other Study ID Numbers: Jan1
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014

Keywords provided by Göteborg University:
Cross-Sectional Studies
Prevalence
Peri-Implantitis

Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases