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Therapeutic Options for Treatment of Burning Mouth Syndrome

Different Therapeutic Options for Burning Mouth Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04475614
Enrollment
62
Registered
2020-07-17
Start date
2018-09-15
Completion date
2019-03-31
Last updated
2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burning Mouth Syndrome

Keywords

burning mouth syndrome, treatment

Brief 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.

Interventions

DIETARY_SUPPLEMENTBioGaia Prodentis lozenges

oral probiotics

PROCEDURElow level laser treatment with Ga-Al-As laser

low level laser treatment

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

intra muscular vitamin injections

Sponsors

University of Zagreb
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
39 Years to 83 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the patient's quality of life using Oral Health Impact Profile 14 questionnaire (OHIP-14)up to two months (follow up was one month after the end of treatment, in each patient)change in the patient's quality of life determined by self-perceived quality of life questionnaire (Oral Health Impact Profile; OHIP-14)

Secondary

MeasureTime frameDescription
Change in subjective burning symptomsup to two months (follow up was one month after the end of treatment, in each patient)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)

Countries

Croatia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026