New Study Shows Intraoral Electrostimulation Has Potential to Treat Dry Mouth in Sjogren’s Syndrome Patients
A study recently published in the Journal of Oral Pathology & Medicine explored a potential non-pharmacological and non-invasive treatment for dry mouth caused by Sjogren’s syndrome.
Entitled “Long-term effectiveness of a novel intraoral electro-stimulator for the treatment of dry mouth in patients with Sjogren’s syndrome: A randomised sham-controlled feasibility study (LEONIDAS-1)”, this UK-based study yielded positive results concerning the effectiveness of intraoral electrostimulation.
This is great news for those who suffer from dry mouth and for distributors of medical treatments who are looking for new ways to help the public.
Background
Sjogren’s syndrome is an immune disorder that manifests in two main symptoms: dry eyes and dry mouth. More than 90% of those with Sjogren’s syndrome report dry mouth, which often leads to a decrease in oral health and overall quality of life.
As of now, Sjogren’s syndrome treatments are few, and those that do exist often have adverse effects such as shortness of breath, headache, nausea, excessive sweating, heart rhythm changes, and more.
Intraoral electrostimulation was studied in the past as a potential non-pharmacological, non-invasive treatment for dry mouth, but the results were incomplete. Researchers in the recent UK-based study sought to delve deeper into the issue and yield more concrete results using our intraoral electrostimulation device.
The purpose of the study was to determine whether this treatment was effective.
The Study
Researchers set up a double-blind and randomized trial using active treatment and a placebo. These parameters ensured that both patients and researchers were unaware of which participants were receiving the real treatment and the placebo. The study was split across two outpatient clinics in the UK: the Oral Medicine and Rheumatology units of University College London Hospital and Birmingham Community Healthcare NHS Trust.
Researchers screened 42 individuals who applied for the study and accepted 30 based on 18 points of inclusion and exclusion criteria. Half the group (15 individuals) received active oral electrostimulation, while the other half (15 individuals) received placebo electrostimulation. Later on in the study, 4 participants dropped out, bringing the total of each group to 13.
The mean age of the participants was 61 years old, and 29 out of 30 original participants were female. 90% of participants were of white ethnicity.
Our company manufactured the active device, a CE-marked second-generation removable custom-made intraoral salivary neuro-electrostimulator. The device delivering the placebo looked identical to the active device and was designed to feel like it was delivering electric pulses — but it didn’t. Participants were told to use the devices for up to 5 minutes per hour, as many times as they wanted throughout each day.
Factors Studied by the Researchers
Researchers set up “feasibility outcome measures,” i.e. points to measure to determine whether the trial was successful.
To determine whether this type of treatment is effective for dry mouth, researchers set up preliminary efficacy primary and secondary measures related to dry mouth. These included:
- Salivary flow rate, which measures the amount of saliva production by the salivary glands. It’s assessed by asking the patient to spit out all saliva possible over a 15 minute
- VAS scores evaluated through a 0-100 mm. VAS refers to the Visual Analog Scale, a reliable measurement tool for the reporting of dry mouth.
- Xerostomia Inventory (XI). Xerostomia is the clinical term for the self-perception of dry mouth and the Inventory is a rating system that includes 11 points. The response to each point has a score between 1 and 5 and the combined total score represents the severity of dry mouth.
Researchers measured these factors at the beginning of the trial and then at participants’ 1, 3, 6 and 12-month checkups to determine whether there was any improvement.
Results
The results of the degree of dry mouth in response to the intraoral electrostimulation device were mainly positive and were as follows:
Measurements | Baseline (before treatment) | 6 months (after treatment) | Comments |
Salivary flow rate (the higher the better) | Active: 0.7 Placebo: 0.7 | Active: 1.9 Placebo: 0.8 | The amount of saliva increased in the “active” group. |
Dry mouth VAS scores (the lower the better) | Active: 7.4 Placebo: 7.5 | Active: 6.9 Placebo: 7.3 | VAS scores decreased in the “active” group. |
XI scores (the lower the better) | Active: 47 Placebo: 45 | Active: 43 Placebo: 45 | Xerostomia scores decreased in the “active” group. |
The measurements reported by the researchers are considered good and reflect an increase in salivary flow and a decrease in dry mouth perception in the group treated with the active device. Those parameters remained almost unchanged in the placebo group.
Conclusion
This type of treatment (intraoral electrostimulation) showed positive results in those who received it as part of the trial group.
Source: Fedele S, Al-Hamad A, Mercadante V, et al. Long-term effectiveness of a novel intra-oral electro-stimulator for the treatment of dry mouth in patients with Sjogren’s syndrome: A randomised sham-controlled feasibility study (LEONIDAS-1). J Oral Pathol Med. 2023;52(7): 619‐627. doi:10.1111/jop.13452
