Efficacy and safety of a new oral saliva equivalent in the management of xerostomia: a national, multicenter, randomized study.

Abstract

OBJECTIVE AND STUDY DESIGN:

The clinical efficacy, safety, and acceptability of a new oral saliva equivalent (Novasial) administered four times daily in the treatment of xerostomia in various medical conditions was compared with that of oxygenated glycerol triester oral spray (Aequasyal) and a moisturizing spray (Biotene) in a 2-week, multicenter, randomized, crossover study. Assessment included patient-based evaluation of mouth dryness score (primary endpoint) with a visual analog scale (VAS), blinded assessment of the oral tissue condition by a four-point ordinal scale, and patient-based assessment of tolerability and acceptability.

RESULTS:

At day 14, Novasial decreased oral mouth dryness by 19.5%, (12.5 ± 22.6 mm, P < .0001 versus baseline), versus 10% (6.6 ± 17.9 mm with Aequasyal, P < .0001 versus Baseline; and P < .0156 versus Novasial) and 13% (8.6 ± 18.9 mm) with Biotene (P < .0001 versus baseline). The 50% decrease in the primary endpoint was not achieved, and the overall efficacy of Novasial and Aequasyal were similar with respect to xerostomia. Novasial was preferred to Aequasyal and Biotene in alleviating taste alteration and chewing difficulty. Treatment compliance was higher with Novasial (P = .0014 versus Aequasyal). The treatments improved the oral condition with equal efficacy and were safe and well tolerated (VAS 72-77 mm).

CONCLUSIONS:

Novasial was a safe, well-tolerated, and acceptable treatment in patients with xerostomia induced by various treatments or pathologic conditions.

• Authors: Michel Salom, Eric Hachulla, Chloé Bertolus, Christophe Deschaumes, Guy Simoneau, Stéphane Mouly
• Journal: Oral surgery, oral medicine, oral pathology and oral radiology (Oral Surg Oral Med Oral Pathol Oral Radiol) Vol. 119 Issue 3 Pg. 301-9 (Mar 2015) ISSN: 2212-4411 [Electronic] United States
• PMID: 25617119 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 Elsevier Inc. All rights reserved.

Chemical References

• Biotene
• Drug Combinations
• Saliva, Artificial
• Triglycerides
• Glucose Oxidase
• Lactoperoxidase
• Muramidase

Topics

• Administration, Oral
• Aged
• Cross-Over Studies
• Drug Combinations
• Egg White
• Female
• Glucose Oxidase (administration & dosage, therapeutic use)
• Humans
• Lactoperoxidase (administration & dosage, therapeutic use)
• Male
• Muramidase (administration & dosage, therapeutic use)
• Saliva, Artificial (administration & dosage, therapeutic use)
• Treatment Outcome
• Triglycerides (administration & dosage, therapeutic use)
• Xerostomia (drug therapy)