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Acitve laser+topical clonazepam for Burning Mouth Syndrome (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

BurnLasCLo Trial Summary

This trial will assess the effectiveness of using low-level laser therapy in combination with topical clonazepam to reduce burning symptoms in postmenopausal women affected by burning mouth syndrome.

Eligible Conditions
  • Burning Mouth Syndrome

BurnLasCLo Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Burning Sensation
Secondary outcome measures
Quality of life- Oral Health Impact Profile

Side effects data

From 2011 Phase 4 trial • 397 Patients • NCT00282828
32%
SOMNOLENCE
19%
HEADACHE
17%
ASTHENIA
14%
LIBIDO DECREASED
13%
NAUSEA
13%
DRY MOUTH
13%
ANOREXIA
13%
INSOMNIA
13%
SEXUAL FUNCTION ABNORMAL
11%
DIARRHEA
11%
ABNORMAL EJACULATION
10%
DIZZINESS
10%
ABNORMAL DREAMS
10%
TREMOR
6%
NERVOUSNESS
6%
PHARYNGITIS
6%
INFECTION
5%
ANXIETY
5%
DYSPEPSIA
5%
THINKING ABNORMAL
3%
COUGH INCREASED
3%
DEPRESSION
3%
PAIN
3%
TOOTH DISORDER
3%
INCREASED APPETITE
2%
TWITCHING
2%
CONSTIPATION
2%
Panic Attack
2%
RASH
2%
Pacemaker inserted
2%
Shortness of Breath
2%
AMNESIA
2%
SWEATING
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertraline and Clonazepam
Venlafaxine
Sertraline and Placebo

BurnLasCLo 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

Find a Location

Who is running the clinical trial?

Universidad Nacional Autonoma de MexicoLead Sponsor
64 Previous Clinical Trials
217,822 Total Patients Enrolled
~5 spots leftby Jun 2025
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