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NCT Number: NCT07344909

Burning Mouth Syndrome: Effects of Occlusal Splint Therapy

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.

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Key information

Conditions

Burning Mouth Syndrome Facial Pain Mouth Diseases Mouth Dryness Neurologic Manifestations Orofacial Pain Pain Pathological Conditions, Signs and Symptoms Salivary Gland Diseases Signs and Symptoms Stomatognathic Diseases Xerostomia

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Malmö university

Malmö, Sweden

Location contact

Department for the orofacial pain and jaw function

CONTACT

[email protected]

0406657000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • fibromyalgia
  • ongoing dental treatment

Treatment and study plan

Essix splint

Device

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

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

Secondary outcomes

  1. 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 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.

  2. 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.

    Subjective description of the perceived mouth dryness using a numeric scale 0-10 where 0 indicates very dry and 10 indicates no dryness.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurelia Ilgunas, Doctor

CONTACT

[email protected]

0406657000

Thomas List, Professor

CONTACT

[email protected]

0406657000

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Registry information

Official study title

The Effects of Essix Splint Therapy on Burning Mouth Syndrome. A Prospective N-of-1 Study.

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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