PMID- 34667494 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220427 IS - 1989-5488 (Print) IS - 1989-5488 (Electronic) IS - 1989-5488 (Linking) VI - 13 IP - 10 DP - 2021 Oct TI - Efficacy and safety of two artificial saliva-based polymers containing 0.1% pilocarpine for treatment of xerostomia: A randomized clinical pilot trial. PG - e994-e1000 LID - 10.4317/jced.58415 [doi] AB - 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. CI - Copyright: (c) 2021 Medicina Oral S.L. FAU - Sarideechaigul, Wilairat AU - Sarideechaigul W AD - Department of Oral Biomedical Science, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand. AD - Neuroscience Research and Development Group, Khon Kaen University, Khon Kaen 40002, Thailand. FAU - Priprem, Aroonsri AU - Priprem A AD - Faculty of Pharmacy, Mahasarakham University, Mahasarakham 44150, Thailand. AD - Melatonin Research Group, Khon Kaen University, Khon Kaen 40002, Thailand. FAU - Limsitthichaikoon, Sucharat AU - Limsitthichaikoon S AD - Department of Pharmaceutical Technology, College of Pharmacy, Rangsit University, Pathum Thani 12000, Thailand. FAU - Phothipakdee, Pensri AU - Phothipakdee P AD - Department of Oral Biomedical Science, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand. FAU - Chaijit, Rajda AU - Chaijit R AD - Department of Preventive Dentistry, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand. FAU - Jorns, Teekayu P AU - Jorns TP AD - Department of Oral Biomedical Science, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand. AD - Neuroscience Research and Development Group, Khon Kaen University, Khon Kaen 40002, Thailand. FAU - Lungruammit, Nopphakhun AU - Lungruammit N AD - Dental Student, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand. FAU - Chaiya, Krittiporn AU - Chaiya K AD - Dental Student, Faculty of Dentistry, Khon Kaen University, Khon Kaen 40002, Thailand. LA - eng PT - Journal Article DEP - 20211001 PL - Spain TA - J Clin Exp Dent JT - Journal of clinical and experimental dentistry JID - 101603132 PMC - PMC8501859 COIS- Conflicts of interest The authors declare that they have no conflicts of interest. EDAT- 2021/10/21 06:00 MHDA- 2021/10/21 06:01 PMCR- 2021/10/01 CRDT- 2021/10/20 06:44 PHST- 2021/03/19 00:00 [received] PHST- 2021/05/24 00:00 [accepted] PHST- 2021/10/20 06:44 [entrez] PHST- 2021/10/21 06:00 [pubmed] PHST- 2021/10/21 06:01 [medline] PHST- 2021/10/01 00:00 [pmc-release] AID - 58415 [pii] AID - 10.4317/jced.58415 [doi] PST - epublish SO - J Clin Exp Dent. 2021 Oct 1;13(10):e994-e1000. doi: 10.4317/jced.58415. eCollection 2021 Oct.