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Efficacy of Oral Diazepam in Decrease Frequency,Severity and Duration of Bruxism in Children With Bruxism in Isfahan in 2014/2015

Efficacy of Oral Diazepam in Decrease Frequency,Severity and Duration of Bruxism in Children With Bruxism in Isfahan in 2014/2015

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016031225780N2
Enrollment
Unknown
Registered
2016-08-21
Start date
2015-06-22
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: To subgroups 3 from both age group, placebo was gave as followa
2-8-year-old: half a placebo tablet 8-12-year-old: a placebo tablet Other study process is similar for placebo and diazepam. Intervention 2: For age group of 2-8 years 2.5 mg Diazepam(code A- half a
Treatment - Drugs
To subgroups 3 from both age group, placebo was gave as followa
2-8-year-old: half a placebo tablet 8-12-year-old: a placebo tablet Other study process is similar for placebo and diazepam.
For age group of 2-8 years 2.5 mg Diazepam(code A- half a 5 mg pill) is considered as low dose and 5 mg Diazepam( code B- half a 10 mg pill) as high dose. For age group of 8-15 years 5 mg Diazepam(co

Sponsors

Vice Chancellor for Research, Isfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria including: Bruxism reported by parents; No previous seizure disorder or abnormal movement during sleep; Age 2-15 years; Not taking any medications that affects the neuromuscular system, such as anticonvulsants, benzodiazepines, muscle relaxant and antidepressants; Visual Analogue Score (VAS) will be calculated for included patients by the score of duration, intensity and frequency of bruxism episodes. Exclusion criteria including: Inability to take a pill; Drug hypersensivity.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Bruxism. Timepoint: 2 Weeks, 1 Month , 3 Month after adminstration. Method of measurement: Questionnaire.

Secondary

MeasureTime frame
Intensity, Frequency. Timepoint: 2 Week, 2 Month, 6 Month. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Sayed Nasser – Mostafavy, Dr Majid Khademian

Vice Chancellor for Research, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan,

m.khademian@med.mui.ac.ir; n_mostafavy@med.mui.ac.ir+98 31 3386 8247

Outcome results

None listed

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