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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| informative | No Intervention | The patients in this group received only verbal and written information about their condition. | |
| oral probiotics | Experimental | 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. |
|
| low level laser treatment | Experimental | 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. |
|
| B-vitamin injections | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioGaia Prodentis lozenges | Dietary Supplement | oral probiotics |
| |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dental Medicine, University of Zagreb | Zagreb | 10000 | Croatia |
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| ID | Term |
|---|---|
| D002054 | Burning Mouth Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014803 | Vitamin B Complex |
| ID | Term |
|---|---|
| D014815 | Vitamins |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| low level laser treatment with Ga-Al-As laser |
| Procedure |
low level laser treatment |
|
| B vitamin injections (Neurobion, Merck, Darmstadt, Germany) | Dietary Supplement | intra muscular vitamin injections |
|
| D020164 |
| Chemical Actions and Uses |