Outcome After Dental Implant Treatment

Periodontitis Clinical Trial

Official title:

Longterm Outcome After Dental Implant Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02671812
• Other study ID #: OF13122003
• Status: Completed
• Start date: November 27, 2014
• Est. completion date: August 2018

Study information

• Verified date: February 2019
• Source: Folktandvården Stockholms län AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Peri-Implantitis
• Periodontitis
• PROMs

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Folktandvården Stockholms län AB	Karolinska Institutet

References & Publications (7)

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. Review. — View Citation

Derks J, Håkansson J, Wennström 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. — View 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. Review. — View 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. Review. — View Citation

Pjetursson BE, Karoussis I, Bürgin W, Brägger U, Lang NP. Patients' satisfaction following implant therapy. A 10-year prospective cohort study. Clin Oral Implants Res. 2005 Apr;16(2):185-93. — View 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.1600-0501.20 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients satisfaction after dental implant treatment	Questionnaire and clinical examination	10 years after implant treatment
Secondary	Complications prevalence	Self reported and registered in patients journal and detected at the clinical examination	10 years after implant treatment
Secondary	Profile of inflamatory markers	Samples of saliva and gingival fluid from healthy and disease sites at both tooth and dental implants will be analyzed	10 years after implant treatment