An interventional study of Essix splint in Burning Mouth Syndrome, Orofacial Pain and Mouth Dryness, sponsored by Malmö University. Not yet recruiting at 1 site in Sweden. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Malmö University · Not applicable, Interventional, and Treatment
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.
47 studies on the registry are indexed under Burning Mouth Syndrome; 6 are open to participants now.
This study's planned enrollment of 12 is below the median of 48 across 38 interventional studies indexed under Burning Mouth Syndrome.
Browse Burning Mouth Syndrome studies →Malmö University is the lead sponsor of 44 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
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
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.
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
Subjective change in pain perception
Subjective perception of the change of pain in percent when wearing the splint and not wearing the splint
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Global impression of change
Subjective change of the condition using Patient Global Impression of Change Scale which scores the global perception of change: the scale is composed of expressions for change, starting with "Very much improved" and ending with "Very much worsened". The first one indicate a positive change and the later indicates a negativ change.
Time frame: 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
Subjective description of the perceived mouth dryness using a numeric scale 0-10 where 0 indicates very dry and 10 indicates no dryness.
Time frame: 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.
Start is estimated for Jan 2026; primary completion for Nov 2026, 9 months later.
Of 15 interventional studies with no phase under Burning Mouth Syndrome, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 33. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Malmö University