The impact of Mindfulness on controlling Awake Bruxism: a clinical study with comparative groups

Effectiveness of Mindfulness-based intervention in controlling Awake Bruxism: a randomized controlled clinical trial

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-9pxcvdr

Enrollment

Registered

2026-03-03

Start date

2025-07-15

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarkers

Interventions

It is a four-arm randomized controlled clinical trial with assessor blinding. Randomization will be performed using computer software (Isfahan, Iran – https://random-allocation-software.software.infor

Eligibility

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Participants must present good general health; own an iOS device with WhatsApp; have cognitive ability to respond to ecological momentary assessment and questionnaires; present a diagnosis of probable awake bruxism based on self-report and clinical signs; be between 18 and 45 years of age; and may be of either sex

Exclusion criteria

Exclusion criteria: Exclusion criteria include the use of psychotropic medications such as anxiolytics antidepressants or muscle relaxants or the use of stimulant substances; uncontrolled psychological or psychiatric conditions such as severe depression anxiety or schizophrenia; neurological disorders such as dystonia or Parkinson disease; severe orofacial pathologies or decompensated systemic conditions; absence of electronic devices compatible with the recording of awake bruxism episodes; and history of treatment for awake bruxism within the last 6 months

Design outcomes

Primary

Measure	Time frame
It is expected that a significant reduction in the frequency of awake bruxism (AB) episodes will be observed after the proposed interventions, verified by comparing the different assessment times (T0, T1, T2, and T3) using the average percentage variation between measurements. The intervention groups are expected to show an average reduction greater than 60% in the frequency of AB episodes, specifically in the comparisons GM: T0 × T2; GIEM: T0 × T1; and GMIEM: T0 × T1 and T1 × T2.;It is also expected to identify an additional positive effect of mindfulness on the cognitive-behavioral and emotional aspects associated with BV, assessed through standardized psychological instruments, especially in groups that receive mindfulness-based interventions.;Finally, the maintenance of results over time will be evaluated through comparative analysis between T2 and T3. It is expected that the groups receiving mindfulness (GM and GMIEM) will maintain the reduction in bouts of vomiting at T3, compared to the group receiving only the momentary ecological intervention, indicating more lasting effects.	—

Measure

Time frame

It is expected that a significant reduction in the frequency of awake bruxism (AB) episodes will be observed after the proposed interventions, verified by comparing the different assessment times (T0, T1, T2, and T3) using the average percentage variation between measurements. The intervention groups are expected to show an average reduction greater than 60% in the frequency of AB episodes, specifically in the comparisons GM: T0 × T2; GIEM: T0 × T1; and GMIEM: T0 × T1 and T1 × T2.;It is also expected to identify an additional positive effect of mindfulness on the cognitive-behavioral and emotional aspects associated with BV, assessed through standardized psychological instruments, especially in groups that receive mindfulness-based interventions.;Finally, the maintenance of results over time will be evaluated through comparative analysis between T2 and T3. It is expected that the groups receiving mindfulness (GM and GMIEM) will maintain the reduction in bouts of vomiting at T3, compared to the group receiving only the momentary ecological intervention, indicating more lasting effects.

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Secondary

Measure	Time frame
No secondary outcomes are expected.	—

Countries

Contacts

Public ContactVictor Hugo Silva

Faculdade de Odontologia de Ribeiro Preto/Universidade de Sao Paulo - FORP/USP

victorhugoribeiro@usp.br+55-34-991693422

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026