A randomized controlled trial on the effect of gastric-acid inhibiting drug on sleep bruxism and oral disease

A randomized controlled trial on the effect of gastric-acid inhibiting drug on sleep bruxism and oral disease - Effect of gastric-acid inhibiting drug on sleep bruxism

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002923

Enrollment

Registered

2009-12-25

Start date

2009-12-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Sleep Bruxism

Interventions

Infusion of an acdic solution into the esophagus (0.1N HCl, 5ml, multiple infusion per night) Infusion of a saline into the esophagus (Saline, 5ml, multiple infusion per night)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Healthy adult without sleep bruxism

Exclusion criteria

Exclusion criteria: 1. Individual with secondary sleep bruxism 2. Individual with sleep disorder except sleep bruxism 3. Individual with gastro-intestinal disease 4. Individual with any medication within three months

Design outcomes

Primary

Measure	Time frame
1. Frequency of sleep bruxism episodes 2. Masticatory muscle activity during sleep	—

Secondary

Measure	Time frame
1. Frequency of tooth grinding noises 2. Frequency of gastro-esophageal reflux episodes 3. Sleep-stage distribution 4. Frequency of micro-arousals 5. Gastrointestinal symptoms on awakening	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026