Therapeutic Options for Treatment of Burning Mouth Syndrome

Burning Mouth Syndrome Clinical Trial

Official title:

Different Therapeutic Options for Burning Mouth Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04475614
• Other study ID #: 01072018
• Status: Completed
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: July 2020
• Source: University of Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 39 Years to 83 Years

Eligibility

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

Related Conditions & MeSH terms

• Burning Mouth Syndrome
• Burns
• Syndrome

Intervention

Dietary Supplement:
• BioGaia Prodentis lozenges
oral probiotics

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

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

Locations

Country	Name	City	State
Croatia	School of Dental Medicine, University of Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)