Intervention study of oral dryness - Armor.

Saliva has an important function in digestion, speech, and maintenance of oral
health. Xerostomia is the subjective feeling of oral dryness, which is often
(but not always) associated with hypofunction of the salivary glands. A
deficiency to produce saliva can be caused by autoimmune disorders (including
Sjögren syndrome), radiotherapy of head and neck, as a side effect of
medication and dehydration. Prolonged periods of xerostomia can hinder chewing,
swallowing and speaking and increase the risk for tooth decay. Xerostomia
patients often experience a significant decreased quality of life. With the
increase in xerostomia in population, there is an urgent need for solutions
that stimulate, complement or replace the salivary functions.

The current study is aimed to evaluate the effect of a novel mouthwash on the
relieve of a dry mouth sensation in Sjögren syndrome patients.

The study is designed as a randomized parallel placebo-controlled double blind
study.

During the intervention a random selection of half of the group of Sjögren
patients will be requested to rinse two times a daily with 15 ml mouthwash for
one minute . The other half of the group of patients will receive a placebo,
and be requested to use it in the same manner as the actual product. This
duration of the trial is 14 days.

We anticipate that the burden and risk of participating in this study is low.
At the salivary clinic an assessment of the dryness of the mouth will be
performed, according to normal clinical practice. After this, the volunteers
that are included in the study will use a mouthwash or rinse with a placebo in
a non-invasive manner, and it is expected that this will relieve their
symptoms of in case of the placebo, have no effect at all. The mouthwash is
tested to be safe and to have no adverse effects.