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CompletedNCT04015349Updated Jul 17, 2019

Clinical Condition and Sleep Quality Factors Associated With Sleep Bruxism in Adults.

An observational study in Sleep Bruxism, Adult, sponsored by Federal University of Pelotas. Completed at 1 site in Brazil. Open to participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-17.

Sponsored by Federal University of Pelotas · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
240
Ages
20 Years to 90 Years
Sex
All
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Study summary

This cross-sectional study will evaluate the association between sociodemographic, occupational, clinical conditions, psychological (sense of coherence), sleep quality variables and SB diagnosed by PSG, the gold standard exam with audio-visual resources obtained at Pelotas Sleep Institute.

Read the detailed description

Sleep bruxism is defined as a masticatory muscle activity during sleep that is characterised as rhythmic (phasic) or non-rhythmic (tonic) and should be considered a risk factor rather than a disorder in otherwise healthy individuals.

The diagnosis of sleep bruxism often is challenging and despite the use of questionnaires, clinical exams and portable devices, based on current knowledge, the polysomnography with audio-video recordings emerges as the gold-standard criteria for a definite sleep bruxism diagnosis.

Included on the questionnaire there is a registration form, which contains: included: age at time of data collection , gender, marital status , and education level ; Occupational: individuals were asked about work outside home, and working hours; Clinical condition: body mass index, smoking; alcohol consumption; use of sleeping pills; respiratory allergy and Psychological: sense of coherence .

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Conditions studied

  • Sleep Bruxism, Adult

Keywords

  • grind
  • polysomnography
  • rhythmic masticatory muscle activity
  • sleep bruxism
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In context

Bruxism

166 studies on the registry are indexed under Bruxism; 38 are open to participants now.

This study's enrollment of 240 is above the median of 90 across 59 observational studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

Federal University of Pelotas is the lead sponsor of 52 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All records obtained from adults (aged 20 to 60 years) and elderly (aged >60 years) who had undergone PSG at a private medical outpatients clinic from July 2017 to February 2018 were reviewed.

Inclusion criteria

  • All adults (aged 20 to 60 years) and elderly (aged >60 years)

Exclusion criteria

Exclusion Criteria:

  • Inadequate cognitive capacity to understand and answer the questionnaires;
  • Degraded PSG image quality;
  • Questionnaires filled incorrectly;
  • Participants who presented a history of epilepsy that could interfere in the results of polysomnography.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
240 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testPolysomnography

    The polysomnography (referred to as type I) allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables documenting tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial (eg, swallowing) and other muscular activity (eg, head movements) during sleep. Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when RMMA episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or RMMA episodes are greater than or equal to 4 (high-frequency SB, severe bruxism)

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What researchers measure

Primary outcomes

  1. Patients with Sleep Bruxism by Polysomnography exams

    The data were obtained from polysomnography records in which masseter electromyography (EMG) burst was detected based on a predefined EMG threshold (20% of maximal voluntary tooth clenching task). Right masseter EMG bursts exceeding 0.25 second in duration were selected for oromotor activity scoring according to published criteria. Oromotor episodes separated by 3-second intervals were recognized as rhythmic masticatory muscle activity (RMMA) if they corresponded to 1 of the 3 following patterns: phasic (3 or more EMG bursts, each lasting 0.25 to 2 seconds), tonic (1 EMG burst lasting more than 2 seconds), or mixed (both burst types) episodes. EMG bursts were considered within the same RMMA episode if the interval between them was shorter than 2 seconds. Participants had SB diagnosed by polysomnography (PSG) if the RMMA index was greater than 2 episodes per hour of sleep.

    Time frame: 4 months

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Study locations

1 site
  • Federal University of Pelotas
    Pelotas, RS 96077590, Brazil
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04015349
Lead sponsor
Federal University of Pelotas
Responsible party
Noéli Boscato, PhD (Associate Professor, Federal University of Pelotas) — Principal investigator
First posted
Jul 11, 2019
Start date
Jul 1, 2017
Primary completion
Nov 1, 2017
Completion
Feb 1, 2018
Last update
Jul 17, 2019

Study contacts

Noéli Boscato, PhD
principal investigator · Federal University of Pelotas

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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