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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.
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.
Age
18 - 80 years
Sex
FEMALE
Healthy Volunteers
No
Malmö university
Malmo, Sweden
Start Date
January 15, 2026
Primary Completion Date
November 1, 2026
Completion Date
November 1, 2027
Last Updated
January 15, 2026
12
ESTIMATED participants
Essix splint
DEVICE
Lead Sponsor
Malmö University
NCT05819697
NCT06754917
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05961501