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Low Level Laser Therapy Plus Topical Clonazepam Treatment to Burning Mouth Symdrome (BurnLasCLo Trial)

Phase 4
Waitlist Available
Research Sponsored by Universidad Nacional Autonoma de Mexico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline of quality of life using ohip-14 at 15 days, 1 month, 2 months, 3 months.
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 10 Other Conditions
Drug Has Already Been Approved

Summary

This trial is testing a special light treatment and a clonazepam mouthwash to help patients with Burning Mouth Syndrome, especially postmenopausal women. The light aims to reduce pain and inflammation, while the mouthwash calms nerve activity. Clonazepam, originally designed as an antiepileptic drug, has been explored for its potential to treat burning mouth syndrome due to its effects as a benzodiazepine.

Eligible Conditions
  • Burning Mouth Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline of burning sensation using visual analogue scale at 15 days, 1 month, 2 months, 3 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline of burning sensation using visual analogue scale at 15 days, 1 month, 2 months, 3 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Burning Sensation
Secondary study objectives
Quality of life- Oral Health Impact Profile

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Acitve laser+topical clonazepamExperimental Treatment1 Intervention
Using active laser (six sesions) 980 nm, 14 j , plus topical clonazepam 1 mg, 3 times at day, same 14 days both
Group II: Sham laser+topical clonazepamPlacebo Group1 Intervention
Using sham laser (six sesions) plus topical clonazepam 1 mg, 3 times at day, same 14 days both
Group III: Active laser+placebo of topical clonazepamPlacebo Group1 Intervention
Using active laser (six sesions) 980 nm, 14 j , plus placebo of topical clonazepam (lactose), 3 times at day, same 14 days both

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Who is running the clinical trial?

Universidad Nacional Autonoma de MexicoLead Sponsor
67 Previous Clinical Trials
218,723 Total Patients Enrolled
~4 spots leftby Dec 2025
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