Burning Mouth SyndromeNCT04475614
Therapeutic Options for Treatment of Burning Mouth Syndrome
A study testing BioGaia Prodentis lozenges, low level laser treatment with Ga-Al-As laser and B vitamin injections (Neurobion, Merck, Darmstadt, Germany) in people with Burning Mouth Syndrome, run by University of Zagreb at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Ages 39 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- BioGaia Prodentis lozenges, low level laser treatment with Ga-Al-As laser and B vitamin injections (Neurobion, Merck, Darmstadt, Germany)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Sep 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- newly diagnosed with burning mouth syndrome and excluded local and systemic causes
Who cannot join
- patients who have received treatment for burning mouth earlier
- patients with local or systemic causes of burning mouth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Burning Mouth Syndrome
- Being tested
- BioGaia Prodentis lozenges, low level laser treatment with Ga-Al-As laser, B vitamin injections (Neurobion, Merck, Darmstadt, Germany)
- Keywords
- burning mouth syndrome, treatment
- Medical subject headings
- Burning Mouth Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioGaia Prodentis lozengesDietary supplement
oral probiotics
low level laser treatment with Ga-Al-As laserProcedure or surgery
low level laser treatment
B vitamin injections (Neurobion, Merck, Darmstadt, Germany)Dietary supplement
intra muscular vitamin injections
| Study group | Role | What they receive |
|---|---|---|
| informative | No intervention | The patients in this group received only verbal and written information about their condition. |
| oral probiotics | Experimental | 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. Receives: Dietary Supplement: BioGaia Prodentis lozenges |
| low level laser treatment | Experimental | 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. Receives: Procedure: low level laser treatment with Ga-Al-As laser |
| B-vitamin injections | Experimental | 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. Receives: Dietary Supplement: B vitamin injections (Neurobion, Merck, Darmstadt, Germany) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to two months (follow up was one month after the end of treatment, in each patient)
Secondary outcomes (1)
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)
Measured: up to two months (follow up was one month after the end of treatment, in each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start15 Sep 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burning Mouth SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Božana Lončar Brzak, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475614
- Sponsor's protocol ID
- 01072018
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Therapeutic Options for Burning Mouth Syndrome
- ClinicalTrials.gov ID
- NCT04475614
- Acronym / sponsor ID
- 01072018
- Conditions
- Burning Mouth Syndrome
- Keywords
- burning mouth syndrome, treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| informative | No intervention | –The patients in this group received only verbal and written information about their condition. |
| oral probiotics | Experimental | Dietary Supplement: BioGaia Prodentis lozengesThe 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. |
| low level laser treatment | Experimental | Procedure: low level laser treatment with Ga-Al-As laserThe 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. |
| B-vitamin injections | Experimental | Dietary Supplement: B vitamin injections (Neurobion, Merck, Darmstadt, Germany)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. |
Who may qualify
- Ages
- 39 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- newly diagnosed with burning mouth syndrome and excluded local and systemic causes
Key exclusion criteria (2 listed)
- patients who have received treatment for burning mouth earlier
- patients with local or systemic causes of burning mouth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioGaia Prodentis lozengesoral probiotics | Dietary supplement | oral probiotics |
| low level laser treatment with Ga-Al-As laserlow level laser treatment | Procedure or surgery | low level laser treatment |
| B vitamin injections (Neurobion, Merck, Darmstadt, Germany)intra muscular vitamin injections | Dietary supplement | B-vitamin injections |
Primary outcome
Change in the patient's quality of life using Oral Health Impact Profile 14 questionnaire (OHIP-14)
Time frame: 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)
1 secondary outcome
Change in subjective burning symptoms
Time frame: up to two months (follow up was one month after the end of treatment, in each patient)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioGaia Prodentis lozenges, low level laser treatment with Ga-Al-As laser and B vitamin injections (Neurobion, Merck, Darmstadt, Germany) in people with Burning Mouth Syndrome, run by University of Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the patient's quality of life using Oral Health Impact Profile 14 questionnaire (OHIP-14) (time frame: up to two months (follow up was one month after the end of treatment, in each patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.