Burning Mouth SyndromeNCT07344909
Burning Mouth Syndrome: Effects of Occlusal Splint Therapy
A study testing Essix splint in people with Burning Mouth Syndrome and Orofacial Pain, run by Malmö University at 1 site in Sweden.
Trial summary
Burning Mouth Syndrome (BMS) causes chronic oral pain and significantly affects quality of life. Effective treatments are limited and often provide only temporary relief. This prospective N-of-1 study evaluates the effect of an intraoral Essix appliance on pain intensity and salivary secretion in patients with BMS. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Burning Mouth Syndrome, Orofacial Pain, Mouth Dryness
- What is being tested?
- Essix splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jan 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with oral mucosal pain from participants in the previous BMS validation study.
- greater than 30% pain relief during prior use of an Essix appliance.
- chronic intraoral pain lasting more than 3 months.
- age between 18 and 80 years.
Who cannot join
- fibromyalgia
- ongoing dental treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Malmö university
Malmö
Department for the orofacial pain and jaw function, 0406657000, osk@mau.se
About this study
Official title: The Effects of Essix Splint Therapy on Burning Mouth Syndrome. A Prospective N-of-1 Study.
Burning Mouth Syndrome (BMS) causes chronic oral pain and significantly affects quality of life. Effective treatments are limited and often provide only temporary relief.
This prospective N-of-1 study evaluates the effect of an intraoral Essix appliance on pain intensity and salivary secretion in patients with BMS.
Saliva samples are collected and analysed for volume and composition.
Read the detailed description
Burning Mouth Syndrome often causes substantial suffering, both due to persistent oral pain and its long-term impact on quality of life, daily activities, and psychological well-being (including depression, anxiety, and stress). Effective treatment options for BMS remain limited, and existing interventions generally demonstrate only modest and temporary benefits.
This study aims to investigate the effect of an Essix appliance on pain relief and salivary secretion in patients with Burning Mouth Syndrome (BMS) using an N-of-1 design, in which each participant serves as their own control.
This is a prospective N-of-1 study designed to assess the treatment effect of an intraorally applied Essix splint compared with periods without splint use. Each participant will use the Essix appliance and have a no-appliance period in randomized order, each lasting one week, separated by a one-week washout period. During the active weeks, saliva samples (both unstimulated and chewing-stimulated) will be collected at home. Additionally, saliva will be collected twice at the Faculty of Odontology in randomized order.
Saliva samples will be analyzed for total protein concentration, with specific focus on lubricating glycoproteins (mucins) using antibody-based methods. Further analyses will employ lectins recognizing specific carbohydrate structures to characterize the glycosylation patterns of salivary glycoproteins and salivary markers.
- Conditions
- Burning Mouth Syndrome, Orofacial Pain, Mouth Dryness
- Being tested
- Essix splint
- Medical subject headings
- Burning Mouth Syndrome, Facial Pain, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essix splintDevice
The treatment effect of an intraorally applied Essix splint compared with periods without splint use. Each participant will use the Essix appliance and have a no-appliance period in randomized order
| Study group | Role | What they receive |
|---|---|---|
| Essix splint | Experimental | The treatment (intraorally applied Essix splint) effect on pain and saliva. Each participant will use the Essix appliance and collect saliva together with a clinical examination and saliva collection at the clinic. A questionary will also be completed. Receives: Device: Essix splint |
| No Essix splint | No intervention | Effect on pain and saliva while not using the splint: collection of saliva together with a clinical examination and saliva collection at the clinic. A questionary will also be completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective change in pain perception
Subjective perception of the change of pain in percent when wearing the splint and not wearing the splint
Measured: two weeks for wearing the splint and two weeks not wearing the splint. The time point for the measurement is during the two clinical appointments - directly after the period with the splint and directly after the period without the splint.
Saliva volume
Saliva volume (rest saliva and stimulated saliva) in milliliters; 10 minutes collection for the rest saliva and 5 minutes collection for the stimulated saliva.
Measured: Twice during the clinical appointments:one directly after the period of 2 weeks after using the splint and the another period directly after 2 weeks when not using the splint; and 8 times collection at home. Saliva collection in the morning hours.
Concentration of glycoproteins in rest saliva
Glycoproteins from the rest saliva measured in mg/mL
Measured: Two occasions -directly after the period of using the splint and after the period of not using the splint. The saliva is collected and then put into the freezer immediately. Analysis starts when whole saliva collection of all participants is finished.
Concentration of proteins in stimulated saliva
Saliva proteins e.g., inflammation-, stress-, or metabolism-related biomarkers from the stimulated saliva, measured in ng/mL.
Measured: Stimulated saliva is collected in two occasions - periods with and without the splint. After the collection saliva is centrifuged immediately and then put into the freezer. Analysis starts when the whole collection is done.
Secondary outcomes (2)
Global impression of change
Subjective change of the condition using Patient Global Impression of Change Scale which scores the global perception of change: the scale is composed of expressions for change, starting with "Very much improved" and ending with "Very much worsened". The first one indicate a positive change and the later indicates a negativ change.
Measured: Twice: after the time period with the splint (two weeks) and after the time period without the splint (two weeks). The score is taken during the clinical appointments - directly after the period with and without the splint.
Subjective perception of mouth dryness
Subjective description of the perceived mouth dryness using a numeric scale 0-10 where 0 indicates very dry and 10 indicates no dryness.
Measured: The score is taken twice: immediatle after the period with the splint (two weeks) and after the period without the splint (two weeks) - during the clinical appointments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
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
- Crossover
- Model description
- N-of-1 design. Two two-week treatment arms with a one-week wash-out period in between.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344909
- Sponsor's protocol ID
- 2025-04647-02
- Other IDs
- 2025
- Status last verified
- Jan 2026
- First submitted
- 26 Nov 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Essix Splint Therapy on Burning Mouth Syndrome. A Prospective N-of-1 Study.
- ClinicalTrials.gov ID
- NCT07344909
- Acronym / sponsor ID
- 2025-04647-02
- Conditions
- Burning Mouth Syndrome, Orofacial Pain, Mouth Dryness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 15 Jan 2026 (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) causes chronic oral pain and significantly affects quality of life. Effective treatments are limited and often provide only temporary relief.
This prospective N-of-1 study evaluates the effect of an intraoral Essix appliance on pain intensity and salivary secretion in patients with BMS.
Saliva samples are collected and analysed for volume and composition.
Detailed description
Burning Mouth Syndrome often causes substantial suffering, both due to persistent oral pain and its long-term impact on quality of life, daily activities, and psychological well-being (including depression, anxiety, and stress). Effective treatment options for BMS remain limited, and existing interventions generally demonstrate only modest and temporary benefits.
This study aims to investigate the effect of an Essix appliance on pain relief and salivary secretion in patients with Burning Mouth Syndrome (BMS) using an N-of-1 design, in which each participant serves as their own control.
This is a prospective N-of-1 study designed to assess the treatment effect of an intraorally applied Essix splint compared with periods without splint use. Each participant will use the Essix appliance and have a no-appliance period in randomized order, each lasting one week, separated by a one-week washout period. During the active weeks, saliva samples (both unstimulated and chewing-stimulated) will be collected at home. Additionally, saliva will be collected twice at the Faculty of Odontology in randomized order.
Saliva samples will be analyzed for total protein concentration, with specific focus on lubricating glycoproteins (mucins) using antibody-based methods. Further analyses will employ lectins recognizing specific carbohydrate structures to characterize the glycosylation patterns of salivary glycoproteins and salivary markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- N-of-1 design. Two two-week treatment arms with a one-week wash-out period in between.
| Arm | Type | Receives |
|---|---|---|
| Essix splint | Experimental | Device: Essix splintThe treatment (intraorally applied Essix splint) effect on pain and saliva. Each participant will use the Essix appliance and collect saliva together with a clinical examination and saliva collection at the clinic. A questionary will also be completed. |
| No Essix splint | No intervention | –Effect on pain and saliva while not using the splint: collection of saliva together with a clinical examination and saliva collection at the clinic. A questionary will also be completed. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with oral mucosal pain from participants in the previous BMS validation study.
- greater than 30% pain relief during prior use of an Essix appliance.
- chronic intraoral pain lasting more than 3 months.
- age between 18 and 80 years.
Key exclusion criteria (2 listed)
- fibromyalgia
- ongoing dental treatment
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 |
|---|---|---|
| Essix splintThe treatment effect of an intraorally applied Essix splint compared with periods without splint use. Each participant will use the Essix appliance and have a no-appliance period in randomized order | Device | Essix splint |
Primary outcome
Subjective change in pain perception
Time frame: two weeks for wearing the splint and two weeks not wearing the splint. The time point for the measurement is during the two clinical appointments - directly after the period with the splint and directly after the period without the splint.
Subjective perception of the change of pain in percent when wearing the splint and not wearing the splint
Saliva volume
Time frame: Twice during the clinical appointments:one directly after the period of 2 weeks after using the splint and the another period directly after 2 weeks when not using the splint; and 8 times collection at home. Saliva collection in the morning hours.
Saliva volume (rest saliva and stimulated saliva) in milliliters; 10 minutes collection for the rest saliva and 5 minutes collection for the stimulated saliva.
Concentration of glycoproteins in rest saliva
Time frame: Two occasions -directly after the period of using the splint and after the period of not using the splint. The saliva is collected and then put into the freezer immediately. Analysis starts when whole saliva collection of all participants is finished.
Glycoproteins from the rest saliva measured in mg/mL
Concentration of proteins in stimulated saliva
Time frame: Stimulated saliva is collected in two occasions - periods with and without the splint. After the collection saliva is centrifuged immediately and then put into the freezer. Analysis starts when the whole collection is done.
Saliva proteins e.g., inflammation-, stress-, or metabolism-related biomarkers from the stimulated saliva, measured in ng/mL.
2 secondary outcomes
Global impression of change
Time frame: Twice: after the time period with the splint (two weeks) and after the time period without the splint (two weeks). The score is taken during the clinical appointments - directly after the period with and without the splint.
Subjective perception of mouth dryness
Time frame: The score is taken twice: immediatle after the period with the splint (two weeks) and after the period without the splint (two weeks) - during the clinical appointments.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essix splint in people with Burning Mouth Syndrome and Orofacial Pain, run by Malmö University at 1 site in Sweden.
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 4 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: opening soon, as of the sponsor's last update on 15 Jan 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurelia Ilgunas, Doctor (0406657000, aurelia.ilgunas@mau.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective change in pain perception (time frame: two weeks for wearing the splint and two weeks not wearing the splint. The time point for the measurement is during the two clinical appointments - directly after the period with the splint and directly after the period without the splint.). The study lists 4 primary outcomes in all. 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 15 Jan 2026.