Burning Mouth Syndrome: Effects of Occlusal Splint Therapy

Malmö University

Status: Not yet enrolling

Conditions: Burning Mouth Syndrome; Mouth Dryness; Orofacial Pain

Treatments: Device: Essix splint

Study type: Interventional

Funder types: Other

Identifiers

NCT07344909

2025-04647-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Essix splint

Experimental group

Description:

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.

Treatment:

Device: Essix splint

No Essix splint

No Intervention group

Description:

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.