Outcome After Dental Implant Treatment

Completed

• Conditions: PROMs; Mucositis; Peri-implantitis; Periodontitis

• Registration Number: NCT02671812
• Lead Sponsor: Folktandvården Stockholms län AB

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.

Study Timeline

• Study Start: 2014-11-27
• Study First Submitted: 2016-01-30
• Study First Submitted QC: 2016-01-30
• Study First Posted: 2016-02-02
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-11
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients satisfaction after dental implant treatment	10 years after implant treatment	Questionnaire and clinical examination

Secondary Outcome Measures

Name	Time	Method
Complications prevalence	10 years after implant treatment	Self reported and registered in patients journal and detected at the clinical examination
Profile of inflamatory markers	10 years after implant treatment	Samples of saliva and gingival fluid from healthy and disease sites at both tooth and dental implants will be analyzed