Clinical Trial: Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Effectiveness of Mucolox® and Clonazepam in Treatment of Burning Mouth Syndrome
Brief 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.
Detailed Summary:
Question:
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.
Study Design:
Randomized, single-blind study to be performed with 3 groups (seen below in treatment arms). Randomization will be performed by computer generated randomization to randomly allocate patients. The patients are not aware of the random group allocation. The study will involve assessment at three phases, once at initial examination (baseline), once at two weeks into treatment, and a final assessment at four weeks.
Treatment Arms:
- Clonazepam (Klonopin®) treatment arm - 1 mg clonazepam (Klonopin® tablet) TID, dissolved in mouth for 3 minutes then expectorated
- Mucolox® only - 5mL Mucolox® TID, swished around mouth for 3 minutes then expectorated.
3. Mucolox® and clonazepam - 1mg Clonazepam/5mL Mucolox® TID, swished around mouth for 3 minutes then expectorated.
Participants - Inclusion/Exclusion Criteria:
Study is open to men and woman. Only will accept patients over the age of 18.
Same as current
Current Secondary Outcome: Effect on quality of life issues using the Brief Pain Inventory [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: University of Alberta
Dates:
Date Received: February 16, 2016
Date Started: April 2016
Date Completion: July 2018
Last Updated: February 19, 2016
Last Verified: February 2016
