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OpenTrials
Completed

NCT Number: NCT02410681

Sleep Bruxism and (Peri-)Implant Complications

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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Key information

Conditions

Dental Implant Complications Bruxism Mental Disorders Nervous System Diseases Parasomnias Sleep Bruxism Sleep Wake Disorders Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Centre for Dentistry Amsterdam (ACTA)

Amsterdam, 1081 LA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electromyographic recording of temporalis muscle activity during sleep

Device

Electromyographic recording of temporalis muscle activity during sleep. In total, 9 sleep recordings will be done at the home setting of each participant.

  • 3 recordings after the baseline visit
  • 3 recordings 6 weeks after the baseline visit
  • 3 recordings one year after the baseline visit

Vertical bitewing radiograph

Radiation

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).

Collection of biofilm sample

Other

Collection of peri-implant intrasulcular biofilm sample for DNA analysis of the biofilm composition. In total, samples will be collected three times:

  • At the baseline visit
  • Three months after the baseline visit
  • One year after the baseline visit

Primary outcomes

  1. Progression of peri-implant marginal bone loss (in mm) during a two-year follow-up period, assessed by intraoral radiographs.

    Time frame: Baseline, two weeks, six weeks, three months, one year, two years.

  2. Changes in the modified Gingival Index during a two-year follow-up period, assessed by probing.

    Time frame: Baseline, two weeks, six weeks, three months, one year, two years.

  3. Changes in the peri-implant clinical pocket depth (in mm) during a two-year follow-up period, assessed by probing.

    Time frame: Baseline, two weeks, six weeks, three months, one year, two years.

  4. Changes in implant mobility (mobility present or not) during a two-year follow-up period, assessed by clinical examination.

    Time frame: Baseline, two weeks, six weeks, three months, one year, two years.

  5. Occurrence and type of implant technical complications, assessed by clinical examination.

    Time frame: Six weeks, three months, one year, two years.

  6. Changes in the peri-implant attachment level (in mm) during a two-year follow-up period, assessed by probing.

    Time frame: Baseline, two weeks, six weeks, three months, one year, two years.

Sponsors and collaborators

Lead sponsor

Frank Lobbezoo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 8, 2015
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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