Burning Mouth Syndrome: Effects of Occlusal Splint Therapy

NCT07344909 | Not Yet Recruiting

• 1 other identifier: 2025-04647-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. Saliva samples are collected and analysed for volume and composition.

Conditions

Burning Mouth Syndrome; Orofacial Pain; Mouth Dryness

Outcome Measures

Primary Outcomes (4)

• Subjective change in pain perception

  Subjective perception of the change of pain in percent when wearing the splint and not wearing the splint

  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.

  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

  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.

  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

  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

  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.

Study Arms (2)

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.

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.

Interventions

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

Essix splint

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• fibromyalgia
• ongoing dental treatment

Sponsors & Collaborators

• Malmö University: lead

Study Sites (1)

Malmö university

Malmo, Sweden

Location

MeSH Terms

Conditions

Burning Mouth Syndrome; Facial Pain; Xerostomia

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Salivary Gland Diseases

Central Study Contacts

Aurelia Ilgunas, Doctor

CONTACT

0406657000; aurelia.ilgunas@mau.se

Thomas List, Professor

CONTACT

0406657000; thomas.list@mau.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: N-of-1 design. Two two-week treatment arms with a one-week wash-out period in between.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 15, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

SE (1)