Sleep Bruxism and (Peri-)Implant Complications

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dental Implant Complications Sleep Bruxism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Electromyographic recording of temporalis muscle activity during sleep

Electromyographic 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

Intervention Type DEVICE

Vertical bitewing radiograph

An 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).

Intervention Type RADIATION

Collection of biofilm sample

Collection 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Planned for treatment with implant-supported fixed suprastructure(s).
* 18 years of age or older.

Exclusion Criteria

* Opposing teeth of implant-supported fixed suprastructure(s) are restored with removable artificial teeth.
* Patients categorized in the classes 3 or higher according to the ASA system for classification of physical status.
* Use of occlusal splint, mandibular repositioning appliance or any other bruxism mitigating device during sleep.
* Active periodontitis at the time of implant placement.
* Known allergy to Grindcare® electrode material.
* Patients with a pacemaker.
* Swollen, infected or inflamed tissues or skin eruptions, e.g. phlebitis, varicose veins etc. in the placement area of the Grindcare® electrode.
* Pregnant women will not be treated with dental implants. Pregnancy after placement of implants will not be a reason to stop participation of the subject in the study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No