Endoscopic treatment of salivary glands affected by Sjögren Syndrome; A pilot study

Sjögren*s syndrome (SS) is an autoimmune inflammatory disorder of the exocrine
glands. It particularly affects the lacrimal and salivary glands. Severe dry
mouth and eyes are frequently reported as presenting symptoms. These symptoms
are in many cases accompanied by nonspecific symptoms, such as malaise and
fatigue. In addition, extraglandular manifestations, like purpura,
polyneuropathy, and arthritis, can be present. SS affects mainly women with a
female/male ratio of 9:1 and can occur at all ages. Due to the irreversible
damage to the saliva producing cells, the quantity and quality of saliva
reduces. The progressive nature of the syndrome results in a further reduction
of salivary flow. Due to hyposalivation the patients suffer from progressive
dental decay, dental erosion, severe drymouth complaints (i.e. eating and
swallowing problems, lack of taste), inflamation of the oral mucosa and lack of
retention of removable dentures. Overall, this can be qualified as a drop in
the quality of life. Until now no effective palliative therapy to relieve dry
mouth complaints is available. A recent case series study suggests that an
endoscopic technique (sialendoscopy) is able to alleviate the symptoms of
patients suffering from SS. In this technique the ducts of the salivary glands
are rinsed with saline and cortisone and possible strictures are dilated. It is
hypothesised that performing a sialendoscopic treatment will raise or restore
(un)stimulated salivary flow levels and enhance the reported mouthfeel score.

The focus of this pilot study is to investigate the results of a sialendoscopy
(with or without rinsing with hydrocortisone 100mg) on the unstimulated whole
mouth (UWS) and stimulated parotid (SP) (ml/min) flow of saliva, oral dryness,
reported mouthfeel and clinical SS symptoms of diagnosed Sjogren*s Syndrome
patients. Also the long-term effects of sialendoscopy on the salivary flow,
oral dryness and subjective changes in mouthfeel are measured.

RCT, blinded

in every participating volunteer a sialendoscopy of the parotid glands and
submandibular glands is performed.

Sialendoscopy is a minimal invasive technique, which is a clinically accepted
in the Netherlands to treat obstructive salivary gland diseases. Sialendoscopy
is performed under general anaesthesia. The burden for participating
volunteers is a consultation visit followed by a 1 day admission on which the
intervention is performed. A reported side effect is post-operative swelling.
One week after the intervention the follow-up schedule is started. In every
visit (except the intervention visit) the patient has to donate saliva by
spitting in a cup and has to fill out questionnaires. With these questionnaires
the change in subjective oral dryness and mouthfeel is recorded. The benefit
for the participating volunteer is a possible reduction of dry-mouth complaints
and (partial) restoration of salivary flow.