PROMsNCT02671812
Outcome After Dental Implant Treatment
An observational study of PROMs and Peri-implantitis, run by Folktandvården Stockholms län AB.
Trial summary
The general aim of this project is to investigate the long-term treatment outcome after implant therapy. The patients' satisfaction with implant treatment will be studied and correlated to biological and technical problems. Read more about this study
- Who is it for?
- Ages 20 to 81 years
- Conditions the study is for
- PROMs, Peri-implantitis, Mucositis
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- 27 Nov 2014to Aug 2018
- 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 20 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients treated with dental implants at the Specialist Clinic Skanstull, Stockholm, Sweden, between 1999-2005
Who may be able to join
- Treated at the Specialist Clinic Skanstull, Stockholm, Sweden with dental implants between the years of 1999-2005
Who cannot join
- Deceased before or during the study period
About this study
Official title: Longterm Outcome After Dental Implant Treatment
The general aim of this project is to investigate the long-term treatment outcome after implant therapy. The patients' satisfaction with implant treatment will be studied and correlated to biological and technical problems. The survival rates of implants at patient level and the degree of bone loss of remaining teeth and implants will be calculated. The levels of cytokines and bone loss markers in peri-implantitis sites and periodontal defects and at healthy sites will be analyzed in order to study the correlation between cytokine and bone loss marker levels, and clinical conditions. Independent variables which could be regarded as significant risk factors or risk predictors on the incidence of peri-implantitis are aimed to be identified
Read the detailed description
- A questionnaire study will investigate patient satisfaction 8-14 years after dental implant therapy to study if complications influence the degree of satisfaction/quality of life. The questionnaire will be sent to 587 patients treated at The Specialist Clinic Skanstull.
- A clinical examination of a minimum 150 patients who answered the questionnaire will be performed:
- to study the incidence of biological and technical complications on dental implants after a minimum of 10 year of function.
- to study the survival rates of implants at patient level and the degree of bone loss of remaining teeth and implants. In addition, the correlation between bone loss of remaining teeth and bone loss of implants will be studied.
- samples taken from the gingival crevicular fluid to investigate the profile of cytokines and bone resorption markers as well as to study the intra-individual correlation of cytokines and bone markers in gingival crevicular fluid from sites with peri-implantitis and periodontal defects in individuals with dental implants.
- in addition, the salivary cytokine and bone resorption markers will be analyzed in order to identify disease-specific biomarkers as well as to study the correlation between the cytokine/bone resorption markers in saliva and in gingival/peri-implant crevicular fluid.
- To identify significant risk factors or risk predictors on the incidence of peri-implantitis.
- Conditions
- PROMs, Peri-implantitis, Mucositis, Periodontitis
- Keywords
- dental implant, patient satisfaction, treatment outcome, cytokine profile, risk factor, risk predictor
- Medical subject headings
- Peri-Implantitis, Mucositis, Periodontitis, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients satisfaction after dental implant treatment
Questionnaire and clinical examination
Measured: 10 years after implant treatment
Secondary outcomes (2)
Complications prevalence
Self reported and registered in patients journal and detected at the clinical examination
Measured: 10 years after implant treatment
Profile of inflamatory markers
Samples of saliva and gingival fluid from healthy and disease sites at both tooth and dental implants will be analyzed
Measured: 10 years after implant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study start27 Nov 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PROMsStudies of the same condition, open and under way.
- 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
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Folktandvården Stockholms län AB
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Leif Jansson, Folktandvården Stockholms län AB
- Investigators
- Margaret Sällberg Chen, Assc. Prof, Study director, Karolinska Institutet Odontologen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671812
- Sponsor's protocol ID
- OF13122003
- Status last verified
- Feb 2019
- First submitted
- 30 Jan 2016
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.
PubMed 25495683Pjetursson BE, Karoussis I, Burgin W, Bragger U, Lang NP. Patients' satisfaction following implant therapy. A 10-year prospective cohort study. Clin Oral Implants Res. 2005 Apr;16(2):185-93. doi: 10.1111/j.1600-0501.2004.01094.x.
PubMed 15777328Derks J, Hakansson J, Wennstrom JL, Klinge B, Berglundh T. Patient-reported outcomes of dental implant therapy in a large randomly selected sample. Clin Oral Implants Res. 2015 May;26(5):586-91. doi: 10.1111/clr.12464. Epub 2014 Aug 14.
PubMed 25123298Heitz-Mayfield LJ. Peri-implant diseases: diagnosis and risk indicators. J Clin Periodontol. 2008 Sep;35(8 Suppl):292-304. doi: 10.1111/j.1600-051X.2008.01275.x.
PubMed 18724857Roccuzzo M, Bonino F, Aglietta M, Dalmasso P. Ten-year results of a three arms prospective cohort study on implants in periodontally compromised patients. Part 2: clinical results. Clin Oral Implants Res. 2012 Apr;23(4):389-95. doi: 10.1111/j.1600-0501.2011.02309.x. Epub 2011 Sep 28.
PubMed 22092445Andreiotelli M, Koutayas SO, Madianos PN, Strub JR. Relationship between interleukin-1 genotype and peri-implantitis: a literature review. Quintessence Int. 2008 Apr;39(4):289-98.
PubMed 19081897Sharma CG, Pradeep AR. Plasma and crevicular fluid osteopontin levels in periodontal health and disease. J Periodontal Res. 2007 Oct;42(5):450-5. doi: 10.1111/j.1600-0765.2007.00968.x.
PubMed 17760823
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Outcome After Dental Implant Treatment
- ClinicalTrials.gov ID
- NCT02671812
- Acronym / sponsor ID
- OF13122003
- Conditions
- PROMs, Peri-implantitis, Mucositis, Periodontitis
- Keywords
- dental implant, patient satisfaction, treatment outcome, cytokine profile, risk factor, risk predictor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Folktandvården Stockholms län ABOther government
- Collaborators
- Karolinska Institutet
- Study start
- 27 Nov 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 2 Feb 2016 (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.
The general aim of this project is to investigate the long-term treatment outcome after implant therapy. The patients' satisfaction with implant treatment will be studied and correlated to biological and technical problems. The survival rates of implants at patient level and the degree of bone loss of remaining teeth and implants will be calculated. The levels of cytokines and bone loss markers in peri-implantitis sites and periodontal defects and at healthy sites will be analyzed in order to study the correlation between cytokine and bone loss marker levels, and clinical conditions. Independent variables which could be regarded as significant risk factors or risk predictors on the incidence of peri-implantitis are aimed to be identified
Detailed description
- A questionnaire study will investigate patient satisfaction 8-14 years after dental implant therapy to study if complications influence the degree of satisfaction/quality of life. The questionnaire will be sent to 587 patients treated at The Specialist Clinic Skanstull.
- A clinical examination of a minimum 150 patients who answered the questionnaire will be performed:
- to study the incidence of biological and technical complications on dental implants after a minimum of 10 year of function.
- to study the survival rates of implants at patient level and the degree of bone loss of remaining teeth and implants. In addition, the correlation between bone loss of remaining teeth and bone loss of implants will be studied.
- samples taken from the gingival crevicular fluid to investigate the profile of cytokines and bone resorption markers as well as to study the intra-individual correlation of cytokines and bone markers in gingival crevicular fluid from sites with peri-implantitis and periodontal defects in individuals with dental implants.
- in addition, the salivary cytokine and bone resorption markers will be analyzed in order to identify disease-specific biomarkers as well as to study the correlation between the cytokine/bone resorption markers in saliva and in gingival/peri-implant crevicular fluid.
- To identify significant risk factors or risk predictors on the incidence of peri-implantitis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated with dental implants at the Specialist Clinic Skanstull, Stockholm, Sweden, between 1999-2005
Key inclusion criteria (1 listed)
- Treated at the Specialist Clinic Skanstull, Stockholm, Sweden with dental implants between the years of 1999-2005
Key exclusion criteria (1 listed)
- Deceased before or during the study period
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
Patients satisfaction after dental implant treatment
Time frame: 10 years after implant treatment
Questionnaire and clinical examination
2 secondary outcomes
Complications prevalence
Time frame: 10 years after implant treatment
Profile of inflamatory markers
Time frame: 10 years after implant treatment
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 14 Jan 2026.
- Results publication: PubMed 25495683Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.
- Results publication: PubMed 15777328Pjetursson BE, Karoussis I, Burgin W, Bragger U, Lang NP. Patients' satisfaction following implant therapy. A 10-year prospective cohort study. Clin Oral Implants Res. 2005 Apr;16(2):185-93. doi: 10.1111/j.1600-0501.2004.01094.x.
- Results publication: PubMed 25123298Derks J, Hakansson J, Wennstrom JL, Klinge B, Berglundh T. Patient-reported outcomes of dental implant therapy in a large randomly selected sample. Clin Oral Implants Res. 2015 May;26(5):586-91. doi: 10.1111/clr.12464. Epub 2014 Aug 14.
- Results publication: PubMed 18724857Heitz-Mayfield LJ. Peri-implant diseases: diagnosis and risk indicators. J Clin Periodontol. 2008 Sep;35(8 Suppl):292-304. doi: 10.1111/j.1600-051X.2008.01275.x.
- Results publication: PubMed 22092445Roccuzzo M, Bonino F, Aglietta M, Dalmasso P. Ten-year results of a three arms prospective cohort study on implants in periodontally compromised patients. Part 2: clinical results. Clin Oral Implants Res. 2012 Apr;23(4):389-95. doi: 10.1111/j.1600-0501.2011.02309.x. Epub 2011 Sep 28.
- Results publication: PubMed 19081897Andreiotelli M, Koutayas SO, Madianos PN, Strub JR. Relationship between interleukin-1 genotype and peri-implantitis: a literature review. Quintessence Int. 2008 Apr;39(4):289-98.
- Results publication: PubMed 17760823Sharma CG, Pradeep AR. Plasma and crevicular fluid osteopontin levels in periodontal health and disease. J Periodontal Res. 2007 Oct;42(5):450-5. doi: 10.1111/j.1600-0765.2007.00968.x.
- Individual participant dataSharing planned: No
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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.
Margaret Sällberg Chen, Assc. Prof study director
Karolinska Institutet Odontologen
Questions about this trial
What is this clinical trial studying?
An observational study of PROMs and Peri-implantitis, run by Folktandvården Stockholms län AB.
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 1 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 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Patients satisfaction after dental implant treatment (time frame: 10 years after implant treatment). 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 NCT02671812, which also lists 7 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 14 Jan 2026.