Burning Mouth Syndrome: Effects of Occlusal Splint Therapy

NCT ID: NCT07344909

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2027-11-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Essix splint

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.

Group Type: EXPERIMENTAL

Essix splint

Intervention Type: 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

No Essix splint

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Essix splint

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Malmö University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Malmö university

Malmo, , Sweden

Countries

Sweden

Central Contacts

Aurelia Ilgunas, Doctor

Role: CONTACT

aurelia.ilgunas@mau.se

0406657000

Thomas List, Professor

Role: CONTACT

thomas.list@mau.se

0406657000

Facility Contacts

Department for the orofacial pain and jaw function

Role: primary

osk@mau.se

0406657000

Other Identifiers

2025-04647-02

Identifier Type: -

Identifier Source: org_study_id