Clinical trial NCT02410681: Sleep Bruxism and (Peri-)Implant Complications
Official title: Associations Between Sleep Bruxism and (Peri-)Implant Complications: a Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implant Complications
Sleep Bruxism
Lead sponsor: Academic Centre for Dentistry in Amsterdam
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with implant-supported fixed suprastructure(s), age 18 years or older.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression of peri-implant marginal bone loss (in mm) during a two-year follow-up period, assessed by intraoral radiographs.
timeFrame: Baseline, two weeks, six weeks, three months, one year, two years.
measure: Changes in the modified Gingival Index during a two-year follow-up period, assessed by probing.
timeFrame: Baseline, two weeks, six weeks, three months, one year, two years.
measure: Changes in the peri-implant clinical pocket depth (in mm) during a two-year follow-up period, assessed by probing.
timeFrame: Baseline, two weeks, six weeks, three months, one year, two years.
measure: Changes in implant mobility (mobility present or not) during a two-year follow-up period, assessed by clinical examination.
timeFrame: Baseline, two weeks, six weeks, three months, one year, two years.
measure: Occurrence and type of implant technical complications, assessed by clinical examination.
timeFrame: Six weeks, three months, one year, two years.
measure: Changes in the peri-implant attachment level (in mm) during a two-year follow-up period, assessed by probing.
timeFrame: Baseline, two weeks, six weeks, three months, one year, two years.
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Centre for Dentistry Amsterdam (ACTA)
Study officials:
affiliation: Academic Centre for Dentistry Amsterdam (ACTA)
name: Frank Lobbezoo, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: