Efficacy and safety of two artificial saliva-based polymers containing 0.1% pilocarpine for treatment of xerostomia: A randomized clinical pilot trial

Wilairat Sarideechaigul; Aroonsri Priprem; Sucharat Limsitthichaikoon; Pensri Phothipakdee; Rajda Chaijit; Teekayu P Jorns; Nopphakhun Lungruammit; Krittiporn Chaiya

doi:10.4317/jced.58415

Efficacy and safety of two artificial saliva-based polymers containing 0.1% pilocarpine for treatment of xerostomia: A randomized clinical pilot trial

J Clin Exp Dent. 2021 Oct 1;13(10):e994-e1000. doi: 10.4317/jced.58415. eCollection 2021 Oct.

Authors

Wilairat Sarideechaigul^{1

2}, Aroonsri Priprem^{3

4}, Sucharat Limsitthichaikoon⁵, Pensri Phothipakdee¹, Rajda Chaijit⁶, Teekayu P Jorns^{1

2}, Nopphakhun Lungruammit⁷, Krittiporn Chaiya⁷

Affiliations

¹ Department of Oral Biomedical Science, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand.
² Neuroscience Research and Development Group, Khon Kaen University, Khon Kaen 40002, Thailand.
³ Faculty of Pharmacy, Mahasarakham University, Mahasarakham 44150, Thailand.
⁴ Melatonin Research Group, Khon Kaen University, Khon Kaen 40002, Thailand.
⁵ Department of Pharmaceutical Technology, College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand.
⁶ Department of Preventive Dentistry, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand.
⁷ Dental Student, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand.

Abstract

Background: Topical agents are the mainstay in the treatment of xerostomia, a common complaint most frequently associated with salivary dysfunction. This study aimed to compared the efficacy and safety for xerostomia treatment of 2 artificial saliva preparations containing 0.1% pilocarpine, and, either sodium carboxymethylcellulose (SCMC), or, sodium polyacrylate (SPA).

Material and methods: Thirty-one xerostomia patients were randomly allocated into either a SCMC-treated group (15 patients), or, a SPA-treated group (16 patients). The formulations were taken 0.5 ml, 4 times daily for 6 weeks and double-blinded assessed before and after treatments using Xerostomia Inventory (XI) and Clinical Oral Dryness Score (CODs). Unstimulated and stimulated whole salivary flow rates were measured.

Results: After treatment, the SCMC-treated group had significantly lower CODs and higher unstimulated and stimulated whole salivary flow rates (p<0.001, p=0.035, and p=0.013, respectively), while the SPA-treated group showed significantly lower CODs only (p=0.004). In contrast, SCMC-treated and SPA-treated groups at the 6th week after treatments showed non-significant differences in all assessments (p>0.05, all). Some adverse events (AEs) were reported, e.g., burning tongue, dizziness and watery eyes, but no severe AEs.

Conclusions: This randomized controlled pilot trial demonstrated superior efficacy of SCMC-formula over a SPA-formula after 6 weeks of xerostomia treatment. These formulations with topical pilocarpine proved safe in clinical use with minimal reported AE. Key words:Xerostomia, artificial saliva, sodium carboxymethylcellulose, sodium polyacrylate, pilocarpine.