Burning Mouth SyndromeburningmouthNCT06217731
Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome
A study testing Laser+clonazepam, Laser and Clonazepam in people with Burning Mouth Syndrome, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Burning Mouth Syndrome (BMS) is a chronic pain disorder that presents with inflammation and burning sensation in the oral cavity without visible lesions. Multiple therapies have been investigated without conclusive results.Objective: To analyse the efficacy of treatment with Clonazepam (Rivotril) and Low Power Diode… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burning Mouth Syndrome
- What is being tested?
- Laser+clonazepam, Laser and Clonazepam
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to 10 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis Burning Mouth Syndrome (BMS) burning sensation in the oral mucosa or recurrent dysesthetics daily for more than 2 hours a day for more than 3 months, without clinically evident causal lesions
Who cannot join
- Pregnant or lactating patients
- Oncology patients
- Sjögren's syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome Before and After Treatment With Low-Level Laser Therapy and Clonazepam: A Randomized, Single-Blind Clinical Trial
Burning Mouth Syndrome (BMS) is a chronic pain disorder that presents with inflammation and burning sensation in the oral cavity without visible lesions. Multiple therapies have been investigated without conclusive results.Objective: To analyse the efficacy of treatment with Clonazepam (Rivotril) and Low Power Diode Laser Therapy in patients with Burning Mouth Syndrome and to study the markers of inflammation present in the patients' saliva.
Methods: Randomised, single-blind clinical trial with 89 patients divided into Group 1 Laser + Rivotril (n=20), Group 2 Laser Sham placebo (n=19), Group 3 Laser (n=21) and Group 4 Rivotril (n=18). The intensity of symptomatology was rated by Visual Analogue Scale (VAS). Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory, the Oral Health Impact Profile-14 (OHIP14) and the Mini-Nutritional Assessment (MNA) were completed. Saliva samples were analysed by measuring markers related to inflammatory processes; Interleukins (IL2, IL4, IL 5, IL6, IL 7, IL 8, IL1β, IL 10, IL12, IL13, IL17, IL21, IL23), proteins (MIP-3α, MIP-1α, MIP-1β), Cytokine GM-CSF, Interferon gamma (IFNγ), Interferon Inducible Tα-Cell Chemoattractant (ITAC), Fractalkine and Tumour Necrosis Factor α(TNFα).
Read the detailed description
Methods: Randomised, single-blind clinical trial with 89 patients divided into Group 1 Laser + Rivotril (n=20), Group 2 Laser Sham placebo (n=19), Group 3 Laser (n=21) and Group 4 Rivotril (n=18). The intensity of symptomatology was rated by Visual Analogue Scale (VAS). Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory, the Oral Health Impact Profile-14 (OHIP14) and the Mini-Nutritional Assessment (MNA) were completed. Saliva samples were analysed by measuring markers related to inflammatory processes; Interleukins (IL2, IL4, IL 5, IL6, IL 7, IL 8, IL1β, IL 10, IL12, IL13, IL17, IL21, IL23), proteins (MIP-3α, MIP-1α, MIP-1β), Cytokine GM-CSF, Interferon gamma (IFNγ), Interferon Inducible Tα-Cell Chemoattractant (ITAC), Fractalkine and Tumour Necrosis Factor α(TNFα).
- Conditions
- Burning Mouth Syndrome
- Being tested
- Laser+clonazepam, Laser Sham, Laser, Clonazepam
- Keywords
- saliva, pain, markers
- Medical subject headings
- Burning Mouth Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser+clonazepamCombination product
treated with the Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month and Rivotril 0.25mg once every 24 hours for a month
Laser ShamDevice
INACTIVE Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
LaserDevice
Active Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month
ClonazepamDrug
Rivotril 0.25mg once every 24 hours for a month
| Study group | Role | What they receive |
|---|---|---|
| Group1 laser + clonazepam | Active comparator | Group 1 (n=20) were treated with the Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month and Rivotril ( clonazepam) 0.25mg once every 24 hours for a month. Receives: Combination Product: Laser+clonazepam |
| group 2 Laser Sham | Sham comparator | Group 2 (n=19) were treated with the same laser once a week for a month, but with the tip deactivated Receives: Device: Laser Sham |
| group3 laser | Experimental | Group 3 (n=21) were treated with the Helbo® laser once a week for a month. Receives: Device: Laser |
| group 4 clonazepam | Experimental | Group 4 (n=18) were treated with Rivotril 0.25mg once a day for a month. Receives: Drug: Clonazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain EVA
The intensity of the symptoms was rated using a Visual Analog Scale (VAS) where 0=no pain and 10=maximum possible pain.
Measured: Baseline through 1 month
Secondary outcomes (1)
salivary biomarkers
salivary biomarkers interleukins (IL2, IL4, IL5, IL6, IL7, IL8, IL1β)
Measured: Baseline through 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start10 Jan 2022
- Primary completion10 Feb 2022
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Lopez Jornet, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06217731
- Sponsor's protocol ID
- Pia Lopez Jornet
- Acronym
- burningmouth
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tan HL, Smith JG, Hoffmann J, Renton T. A systematic review of treatment for patients with burning mouth syndrome. Cephalalgia. 2022 Feb;42(2):128-161. doi: 10.1177/03331024211036152. Epub 2021 Aug 18.
PubMed 34404247Alvarenga-Brant R, Costa FO, Mattos-Pereira G, Esteves-Lima RP, Belem FV, Lai H, Ge L, Gomez RS, Martins CC. Treatments for Burning Mouth Syndrome: A Network Meta-analysis. J Dent Res. 2023 Feb;102(2):135-145. doi: 10.1177/00220345221130025. Epub 2022 Oct 8.
PubMed 36214096Liu YF, Kim Y, Yoo T, Han P, Inman JC. Burning mouth syndrome: a systematic review of treatments. Oral Dis. 2018 Apr;24(3):325-334. doi: 10.1111/odi.12660. Epub 2017 Mar 30.
PubMed 28247977
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Markers in Saliva of Patients With Burning Mouth Syndrome Before and After Treatment With Low-Level Laser Therapy and Clonazepam: A Randomized, Single-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT06217731
- Acronym / sponsor ID
- burningmouth / Pia Lopez Jornet
- Conditions
- Burning Mouth Syndrome
- Keywords
- saliva, pain, markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 22 Jan 2024 (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 (BMS) is a chronic pain disorder that presents with inflammation and burning sensation in the oral cavity without visible lesions. Multiple therapies have been investigated without conclusive results.Objective: To analyse the efficacy of treatment with Clonazepam (Rivotril) and Low Power Diode Laser Therapy in patients with Burning Mouth Syndrome and to study the markers of inflammation present in the patients' saliva.
Methods: Randomised, single-blind clinical trial with 89 patients divided into Group 1 Laser + Rivotril (n=20), Group 2 Laser Sham placebo (n=19), Group 3 Laser (n=21) and Group 4 Rivotril (n=18). The intensity of symptomatology was rated by Visual Analogue Scale (VAS). Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory, the Oral Health Impact Profile-14 (OHIP14) and the Mini-Nutritional Assessment (MNA) were completed. Saliva samples were analysed by measuring markers related to inflammatory processes; Interleukins (IL2, IL4, IL 5, IL6, IL 7, IL 8, IL1β, IL 10, IL12, IL13, IL17, IL21, IL23), proteins (MIP-3α, MIP-1α, MIP-1β), Cytokine GM-CSF, Interferon gamma (IFNγ), Interferon Inducible Tα-Cell Chemoattractant (ITAC), Fractalkine and Tumour Necrosis Factor α(TNFα).
Detailed description
Methods: Randomised, single-blind clinical trial with 89 patients divided into Group 1 Laser + Rivotril (n=20), Group 2 Laser Sham placebo (n=19), Group 3 Laser (n=21) and Group 4 Rivotril (n=18). The intensity of symptomatology was rated by Visual Analogue Scale (VAS). Sialometry was performed before and after treatment and questionnaires such as the Xerostomia Inventory, the Oral Health Impact Profile-14 (OHIP14) and the Mini-Nutritional Assessment (MNA) were completed. Saliva samples were analysed by measuring markers related to inflammatory processes; Interleukins (IL2, IL4, IL 5, IL6, IL 7, IL 8, IL1β, IL 10, IL12, IL13, IL17, IL21, IL23), proteins (MIP-3α, MIP-1α, MIP-1β), Cytokine GM-CSF, Interferon gamma (IFNγ), Interferon Inducible Tα-Cell Chemoattractant (ITAC), Fractalkine and Tumour Necrosis Factor α(TNFα).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 laser + clonazepam | Active comparator | Combination Product: Laser+clonazepamGroup 1 (n=20) were treated with the Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month and Rivotril ( clonazepam) 0.25mg once every 24 hours for a month. |
| group 2 Laser Sham | Sham comparator | Device: Laser ShamGroup 2 (n=19) were treated with the same laser once a week for a month, but with the tip deactivated |
| group3 laser | Experimental | Device: LaserGroup 3 (n=21) were treated with the Helbo® laser once a week for a month. |
| group 4 clonazepam | Experimental | Drug: ClonazepamGroup 4 (n=18) were treated with Rivotril 0.25mg once a day for a month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis Burning Mouth Syndrome (BMS) burning sensation in the oral mucosa or recurrent dysesthetics daily for more than 2 hours a day for more than 3 months, without clinically evident causal lesions
Key exclusion criteria (3 listed)
- Pregnant or lactating patients
- Oncology patients
- Sjögren's syndrome
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 |
|---|---|---|
| Laser+clonazepamtreated with the Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month and Rivotril 0.25mg once every 24 hours for a month | Combination product | Group1 laser + clonazepam |
| Laser ShamINACTIVE Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month | Device | group 2 Laser Sham |
| LaserActive Helbo® Theralite Laser 3D Pocket Probe low power diode laser once a week for a month | Device | group3 laser |
| ClonazepamRivotril 0.25mg once every 24 hours for a month | Drug | group 4 clonazepam |
Primary outcome
Pain EVA
Time frame: Baseline through 1 month
The intensity of the symptoms was rated using a Visual Analog Scale (VAS) where 0=no pain and 10=maximum possible pain.
1 secondary outcome
salivary biomarkers
Time frame: Baseline through 1 month
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 31 Jul 2024.
- Background: PubMed 34404247Tan HL, Smith JG, Hoffmann J, Renton T. A systematic review of treatment for patients with burning mouth syndrome. Cephalalgia. 2022 Feb;42(2):128-161. doi: 10.1177/03331024211036152. Epub 2021 Aug 18.
- Background: PubMed 36214096Alvarenga-Brant R, Costa FO, Mattos-Pereira G, Esteves-Lima RP, Belem FV, Lai H, Ge L, Gomez RS, Martins CC. Treatments for Burning Mouth Syndrome: A Network Meta-analysis. J Dent Res. 2023 Feb;102(2):135-145. doi: 10.1177/00220345221130025. Epub 2022 Oct 8.
- Background: PubMed 28247977Liu YF, Kim Y, Yoo T, Han P, Inman JC. Burning mouth syndrome: a systematic review of treatments. Oral Dis. 2018 Apr;24(3):325-334. doi: 10.1111/odi.12660. Epub 2017 Mar 30.
- Individual participant dataSharing planned: Undecided
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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 Laser+clonazepam, Laser and Clonazepam in people with Burning Mouth Syndrome, run by Universidad de Murcia at 1 site in Spain.
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 3 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 31 Jul 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Pain EVA (time frame: Baseline through 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06217731, which also lists 3 linked publications.
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 31 Jul 2024.