Back to resultsTherapeutic Options for Treatment of Burning Mouth Syndrome
Primary Purpose
Burning Mouth Syndrome
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
BioGaia Prodentis lozenges
low level laser treatment with Ga-Al-As laser
B vitamin injections (Neurobion, Merck, Darmstadt, Germany)
Sponsored by
About this trial
This is an interventional treatment trial for Burning Mouth Syndrome focused on measuring burning mouth syndrome, treatment
Eligibility Criteria
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
Sites / Locations
- School of Dental Medicine, University of Zagreb
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
informative
oral probiotics
low level laser treatment
B-vitamin injections
Arm Description
The patients in this group received only verbal and written information about their condition.
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.
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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04475614
Brief Title
Therapeutic Options for Treatment of Burning Mouth Syndrome
Official Title
Different Therapeutic Options for Burning Mouth Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
March 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zagreb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burning Mouth Syndrome
Keywords
burning mouth syndrome, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
informative
Arm Type
No Intervention
Arm Description
The patients in this group received only verbal and written information about their condition.
Arm Title
oral probiotics
Arm Type
Experimental
Arm Description
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.
Arm Title
low level laser treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
B-vitamin injections
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
BioGaia Prodentis lozenges
Intervention Description
oral probiotics
Intervention Type
Procedure
Intervention Name(s)
low level laser treatment with Ga-Al-As laser
Intervention Description
low level laser treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
B vitamin injections (Neurobion, Merck, Darmstadt, Germany)
Intervention Description
intra muscular vitamin injections
Primary Outcome Measure Information:
Title
Change in the patient's quality of life using Oral Health Impact Profile 14 questionnaire (OHIP-14)
Description
change in the patient's quality of life determined by self-perceived quality of life questionnaire (Oral Health Impact Profile; OHIP-14)
Time Frame
up to two months (follow up was one month after the end of treatment, in each patient)
Secondary Outcome Measure Information:
Title
Change in subjective burning symptoms
Description
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)
Time Frame
up to two months (follow up was one month after the end of treatment, in each patient)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
83 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
School of Dental Medicine, University of Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Therapeutic Options for Treatment of Burning Mouth Syndrome
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