Clinical trial NCT02671812: Outcome After Dental Implant Treatment
Official title: Longterm Outcome After Dental Implant Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PROMs
Peri-implantitis
Mucositis
Periodontitis
Keywords: dental implant
patient satisfaction
treatment outcome
cytokine profile
risk factor
risk predictor
Lead sponsor: Folktandvården Stockholms län AB
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2016-02-02
Enrollment: 163
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated with dental implants at the Specialist Clinic Skanstull, Stockholm, Sweden, between 1999-2005

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

- Treated at the Specialist Clinic Skanstull, Stockholm, Sweden with dental implants between the years of 1999-2005

Exclusion Criteria:

- Deceased before or during the study period

Primary outcomes:
measure: Patients satisfaction after dental implant treatment
timeFrame: 10 years after implant treatment
Secondary outcomes:
measure: Complications prevalence
timeFrame: 10 years after implant treatment
measure: Profile of inflamatory markers
timeFrame: 10 years after implant treatment
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet Odontologen
name: Margaret Sällberg Chen, Assc. Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Pjetursson 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.
citation: Derks 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.
citation: Heitz-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.
citation: Roccuzzo 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.
citation: Andreiotelli 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.
citation: Sharma 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.