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Sleep Bruxism and (Peri-)Implant Complications

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ClinicalTrials.gov Identifier: NCT02410681
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Frank Lobbezoo, Academic Centre for Dentistry in Amsterdam

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.

Condition or disease Intervention/treatment
Dental Implant Complications Sleep Bruxism Device: Electromyographic recording of temporalis muscle activity during sleep Radiation: Vertical bitewing radiograph Other: Collection of biofilm sample

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Associations Between Sleep Bruxism and (Peri-)Implant Complications: a Follow-up Study
Study Start Date : March 2015
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Intervention Details:
  • Device: 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
  • Radiation: 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).
  • Other: 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


Primary Outcome Measures :
  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. ]

Biospecimen Retention:   Samples With DNA
Peri-implant intrasulcular biofilm.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with implant-supported fixed suprastructure(s), age 18 years or older.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410681


Locations
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Netherlands
Academic Centre for Dentistry Amsterdam (ACTA)
Amsterdam, Netherlands, 1081 LA
Sponsors and Collaborators
Frank Lobbezoo
Investigators
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Principal Investigator: Frank Lobbezoo, Prof. Dr. Academic Centre for Dentistry Amsterdam (ACTA)

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Responsible Party: Frank Lobbezoo, Prof. Dr., Academic Centre for Dentistry in Amsterdam
ClinicalTrials.gov Identifier: NCT02410681     History of Changes
Other Study ID Numbers: ACTA_2012-2015
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Bruxism
Sleep Bruxism
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders