Therapeutic Options for Treatment of Burning Mouth Syndrome

Different Therapeutic Options for Burning Mouth Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Burning Mouth Syndrome
• Intervention / Treatment: Dietary supplement: BioGaia Prodentis lozenges; Procedure: low level laser treatment with Ga-Al-As laser; Dietary supplement: B vitamin injections (Neurobion, Merck, Darmstadt, Germany)

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • School of Dental Medicine, University of Zagreb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 39 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: informative; The patients in this group received only verbal and written information about their condition.
Experimental: 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.	Dietary supplement: BioGaia Prodentis lozenges; oral probiotics
Experimental: 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.	Procedure: low level laser treatment with Ga-Al-As laser; low level laser treatment
Experimental: 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.	Dietary supplement: B vitamin injections (Neurobion, Merck, Darmstadt, Germany); intra muscular vitamin injections

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: treatment; burning mouth syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Stomatognathic Diseases; Mouth Diseases; Syndrome; Burns; Burning Mouth Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex
• Other Study ID Numbers: 01072018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No