Burning Mouth Syndrome: Effects of Occlusal Splint Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Subjective change in pain perception — 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
• Saliva volume — 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.
• Concentration of glycoproteins in rest saliva — 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
• Concentration of proteins in stimulated saliva — 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.

Trial sites (1)

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