The effect of hydroxyzine on bruxism

Randomized placebo controlled clinical trial of the effect of hydroxyzine on bruxism in children and adolescents

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201110203930N13

Enrollment

Registered

2012-07-23

Start date

2011-10-25

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Bruxism. Other somatoform disorders

Interventions

Intervention 1: Hydroxizine, 25 – 50 mg/day. Intervention 2: Placebo.

Treatment - Drugs

Placebo

Hydroxizine, 25 – 50 mg/day

Eligibility

Sex/Gender

All

Age

3 Years to 17 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Children with age range of 3 to 17 years from both gender with bruxism. Exclusion criteria: Concurrent behavior therapy, psychoanalysis, or relaxation therapy for bruxism; taking benzodiazepines.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Visual Analogue scale. Timepoint: Pre and post intervention. Method of measurement: Parent report.	—

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026