Peri-ImplantitisNCT01825772
Clinical and Radiographic Outcomes of Dental Implant Therapy
An observational study of Peri-Implantitis, run by Göteborg University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Peri-Implantitis
- How many people
- 596 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Having died during the study period (collection of questionnaire and patient files/records)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Periodontology, Institute of Odontology
Gothenburg, 40530
About this study
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.
Read more
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
- Medical subject headings
- Peri-Implantitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implantitis
All subjects were provided with dental implants in 2003/2004. The clinical and radiographic examinations will be carried out in 2013.
Measured: 9-10 years following implant installation
Secondary outcomes (1)
Implant loss
Measured: 9-10 years after having received dental implants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Social Insurance Agency
- Responsible party
- Sponsor
- Investigators
- Tord Berglundh, Professor, Study director, Göteborg UniversityJan Derks, PhD Student, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825772
- Sponsor's protocol ID
- Jan1
- Status last verified
- Mar 2022
- First submitted
- 3 Apr 2013
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16117768Tomasi 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.
PubMed 22533958Berglundh 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.
PubMed 12787220Derks 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.
PubMed 26900869Derks 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.
PubMed 26701919Derks 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.
PubMed 25503901
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Dental Implant Therapy
- ClinicalTrials.gov ID
- NCT01825772
- Acronym / sponsor ID
- Jan1
- Conditions
- Peri-Implantitis
- Keywords
- Cross-Sectional Studies, Prevalence, Peri-Implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Social Insurance Agency
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Having died during the study period (collection of questionnaire and patient files/records)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Implant loss
Time frame: 9-10 years after having received dental implants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 16117768Fransson 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.
- Background: PubMed 22533958Tomasi 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.
- Background: PubMed 12787220Berglundh 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.
- Derived from this study: PubMed 26900869Derks 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.
- Derived from this study: PubMed 26701919Derks 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.
- Derived from this study: PubMed 25503901Derks 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tord Berglundh, Professor study director
Göteborg University
Jan Derks, PhD Student principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis, run by Göteborg University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implantitis (time frame: 9-10 years following implant installation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01825772, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.