Saliva substitute in xerostomic patients with primary Sjögren's syndrome: a single-blind trial.
OBJECTIVE
To evaluate the efficacy of oral moisturizing gel (Oral Balance) in xerostomic patients with primary Sjögren's syndrome (SS).


METHODS
Twenty-one xerostomic patients with primary SS were subjected to a single-blind trial in which the efficacy of Oral Balance gel in reducing xerostomia and xerostomia-related oral symptoms was compared with that of a placebo. Both gels were packaged identically and were indiscernible in appearance and taste. Xerostomia was confirmed for all the patients through measurement of stimulated whole saliva. Patients began using the Oral Balance gel three times a day for 90 days, and were then switched to a gel placebo to be used in the same way for the same length of time. Clinical response was evaluated through the patients' subjective assessment (improved, worsened, or unaltered) of both gels.


RESULTS
Neither the Oral Balance gel nor the gel placebo affected the salivary output of the patients. The Oral Balance gel presented a substantial statistically significant advantage in the control of burning mouth, mastication, and swallowing. No statistically significant relief of the isolated sensation of oral dryness was established.


CONCLUSIONS
Oral Balance is a useful tool in the management of dryness-related oral symptoms in primary SS, but there is room for enhancing the overall properties of topical preparations designed to reduce oral complaints in xerostomic patients.
Alves
Marilene B
MB
Department of Oral Diagnosis, University of São Paulo School of Dentistry, São Paulo, Brazil.
Motta
Ana C F
AC
Messina
Waldenise C
WC
Migliari
Dante A
DA
D000328:Adult; D000368:Aged; D002054:Burning Mouth Syndrome / Q000517:prevention & control; D003679:Deglutition / Q000502:physiology; D005260:Female; D006801:Humans; D007784:Lactoperoxidase / Q000627:therapeutic use; D008409:Mastication / Q000502:physiology; D008875:Middle Aged; D010919:Placebos; D011108:Polymers / Q000627:therapeutic use; D011109:Polymethacrylic Acids / Q000627:therapeutic use; D012463:Saliva / Q000378:metabolism; D012464:Saliva, Artificial / Q000627:therapeutic use*; D012636:Secretory Rate / Q000502:physiology; D016037:Single-Blind Method; D012859:Sjogren's Syndrome / Q000150:complications*; D016896:Treatment Outcome; D014987:Xerostomia / Q000503:physiopathology / Q000517:prevention & control*
C114318:Oral Balance; D010919:Placebos; D011108:Polymers; D011109:Polymethacrylic Acids; D012464:Saliva, Artificial; D007784:Lactoperoxidase