Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome

• Status: Withdrawn
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

What affect does the use of a mucoadhesive drug delivery system (Mucolox®) compounded with clonazepam have in the treatment of burning mouth syndrome?

There are no clinical trials reported in the literature that evaluate the use of a mucoadhesive vehicle to deliver clonazepam into the oral cavity and treat burning mouth syndrome. The use of a mucoadhesive may help to increase surface contact and elicit a greater reduction in symptoms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alberta
• Treatments: Clonazepam

Criteria

Inclusion Criteria:

• Presence of burning mouth symptoms that cannot be attributed to any other organic cause.

Exclusion Criteria:

• Laboratory examination will be performed and serum levels of iron, ferritin, folate, vitamin B12 and glucose will be measured. Normal levels required.

• Use of anxiolytic or antidepressant for less than 6 months prior to study.

• Resting salivary flow rates less than 0.1ml/min.

• Presence of oral mucosal disease.