Therapeutic Options for Treatment of Burning Mouth Syndrome

Study Overview
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Brief Summary
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Burning mouth syndrome is a painful condition of unknown etiology that impairs the quality of life and does not have an adequate therapeutic option. The purpose of this study is to determine the most effective treatment option for burning mouth syndrome, among oral probiotics, low-level laser, B-vitamin injections and informative treatment only.

Official Title
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Different Therapeutic Options for Burning Mouth Syndrome

Conditions
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Burning Mouth Syndrome

Intervention / Treatment
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* Dietary Supplement: BioGaia Prodentis lozenges
* Procedure: low level laser treatment with Ga-Al-As laser
* Dietary Supplement: B vitamin injections (Neurobion, Merck, Darmstadt, Germany)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed with burning mouth syndrome and excluded local and systemic causes Exclusion Criteria: patients who have received treatment for burning mouth earlier patients with local or systemic causes of burning mouth

Ages Eligible for Study
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Minimum Age: 39 Years
Maximum Age: 83 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: informative<br>The patients in this group received only verbal and written information about their condition. | |
| Experimental: oral probiotics<br>The patients in this group, beside verbal and written information about their condition, received also oral probiotics. They were instructed to melt one lozenge in the mouth in the evening, after tooth brushing and flossing, for one month. | Dietary Supplement: BioGaia Prodentis lozenges<br>* oral probiotics<br>|
| Experimental: low level laser treatment<br>The patients in this group, beside verbal and written information about their condition, received a total of ten low level laser treatments, for ten days consecutively excluding weekends. | Procedure: low level laser treatment with Ga-Al-As laser<br>* low level laser treatment<br>|
| Experimental: B-vitamin injections<br>The patients in this group, beside verbal and written information about their condition, received a total of nine B vitamin injections, every other day, intra muscular. | Dietary Supplement: B vitamin injections (Neurobion, Merck, Darmstadt, Germany)<br>* intra muscular vitamin injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the patient's quality of life using Oral Health Impact Profile 14 questionnaire (OHIP-14) | change in the patient's quality of life determined by self-perceived quality of life questionnaire (Oral Health Impact Profile; OHIP-14) | up to two months (follow up was one month after the end of treatment, in each patient) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subjective burning symptoms | change of patient's subjective burning symptoms measured on visual analogue scale (VAS) grading from 0 to 10 (0- without burning, 10- the worst possible burning) | up to two months (follow up was one month after the end of treatment, in each patient) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burning mouth syndrome, treatment