Clinical Trials Directory

Trials / Completed

CompletedNCT02410681

Sleep Bruxism and (Peri-)Implant Complications

Associations Between Sleep Bruxism and (Peri-)Implant Complications: a Follow-up Study

Status
Completed
Phase
Study type
Observational
Enrollment
11 (actual)
Sponsor
Frank Lobbezoo · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Excessive mechanical forces can cause complications of dental implants and their suprastructures (crowns and bridges), and can possibly be destructive for the bone and soft tissues around the implants. Sleep bruxism (grinding and clenching of the teeth during sleep) is considered as an important source of mechanical forces in the oral environment. Therefore, in this study, the investigators will investigate whether sleep bruxism is associated with implant and peri-implant complications.

Conditions

Interventions

TypeNameDescription
DEVICEElectromyographic recording of temporalis muscle activity during sleepElectromyographic recording of temporalis muscle activity during sleep. In total, 9 sleep recordings will be done at the home setting of each participant. 1. 3 recordings after the baseline visit 2. 3 recordings 6 weeks after the baseline visit 3. 3 recordings one year after the baseline visit
RADIATIONVertical bitewing radiographAn intraoral vertical bitewing radiograph will be performed with the assistance of individually modified plate positioning devices at each visit (in total 8 visits during the 2-year follow-up period).
OTHERCollection of biofilm sampleCollection of peri-implant intrasulcular biofilm sample for DNA analysis of the biofilm composition. In total, samples will be collected three times: 1. At the baseline visit 2. Three months after the baseline visit 3. One year after the baseline visit

Timeline

Start date
2015-03-01
Primary completion
2019-05-01
Completion
2019-05-01
First posted
2015-04-08
Last updated
2019-07-10

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT02410681. Inclusion in this directory is not an endorsement.