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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04475614
Other study ID # 01072018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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