Health TrialsbyHealthPanel

Burning Mouth Syndrome: Effects of Occlusal Splint Therapy

ConditionsBurning Mouth SyndromeOrofacial PainMouth Dryness
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorMalmö University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

fibromyalgia

ongoing dental treatment

Trial design

Design model

Crossover

Treatments tested in this trial

  • Essix splint

    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

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Essix splintExperimental treatment 1 intervention
Group B: No Essix splintNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.
2

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.
3

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.
4

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.

Secondary outcomes

1

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.
2

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Malmö University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: