Therapeutic Options for Treatment of Burning Mouth Syndrome

University of Zagreb

Status: Completed

Conditions: Burning Mouth Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04475614

01072018

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 39 to 83 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 4 patient groups

informative

No Intervention group

Description:

The patients in this group received only verbal and written information about their condition.

oral probiotics

Experimental group

Description:

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.

Treatment:

Dietary Supplement: BioGaia Prodentis lozenges

low level laser treatment

Experimental group

Description:

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.

Treatment:

Procedure: low level laser treatment with Ga-Al-As laser

B-vitamin injections

Experimental group

Description:

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.

Treatment:

Dietary Supplement: B vitamin injections (Neurobion, Merck, Darmstadt, Germany)