Therapeutic Options for Treatment of Burning Mouth Syndrome

NCT ID: NCT04475614

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2019-03-31

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.

Detailed Description

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Conditions

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Burning Mouth Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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informative

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

Group Type NO_INTERVENTION

No interventions assigned to this group

oral probiotics

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.

Group Type EXPERIMENTAL

BioGaia Prodentis lozenges

Intervention Type DIETARY_SUPPLEMENT

oral probiotics

low level laser treatment

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.

Group Type EXPERIMENTAL

low level laser treatment with Ga-Al-As laser

Intervention Type PROCEDURE

low level laser treatment

B-vitamin injections

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.

Group Type EXPERIMENTAL

B vitamin injections (Neurobion, Merck, Darmstadt, Germany)

Intervention Type DIETARY_SUPPLEMENT

intra muscular vitamin injections

Interventions

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BioGaia Prodentis lozenges

oral probiotics

Intervention Type DIETARY_SUPPLEMENT

low level laser treatment with Ga-Al-As laser

low level laser treatment

Intervention Type PROCEDURE

B vitamin injections (Neurobion, Merck, Darmstadt, Germany)

intra muscular vitamin injections

Intervention Type DIETARY_SUPPLEMENT

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
Minimum Eligible Age

39 Years

Maximum Eligible Age

83 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Božana Lončar Brzak

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Dental Medicine, University of Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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01072018

Identifier Type: -

Identifier Source: org_study_id

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