Dental Implant Complications, Sleep Bruxism
Conditions
Brief 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.
Interventions
DEVICEElectromyographic 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
RADIATIONVertical 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).
OTHERCollection 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
Sponsors
Frank Lobbezoo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of peri-implant marginal bone loss (in mm) during a two-year follow-up period, assessed by intraoral radiographs. | Baseline, two weeks, six weeks, three months, one year, two years. |
| Changes in the modified Gingival Index during a two-year follow-up period, assessed by probing. | Baseline, two weeks, six weeks, three months, one year, two years. |
| Changes in the peri-implant clinical pocket depth (in mm) during a two-year follow-up period, assessed by probing. | Baseline, two weeks, six weeks, three months, one year, two years. |
| Changes in implant mobility (mobility present or not) during a two-year follow-up period, assessed by clinical examination. | Baseline, two weeks, six weeks, three months, one year, two years. |
| Occurrence and type of implant technical complications, assessed by clinical examination. | Six weeks, three months, one year, two years. |
| Changes in the peri-implant attachment level (in mm) during a two-year follow-up period, assessed by probing. | Baseline, two weeks, six weeks, three months, one year, two years. |
Countries
Netherlands
Outcome results
None listed