A Clinical Study on the Efficacy and Tolerability of a New Topical Gel and Toothpaste in Patients with Xerostomia: A Randomized Controlled Trial

Abstract

Objective: xerostomia is a very common problem in the general population. The objective of this study was to determine the efficacy of a new gel and toothpaste in patients with xerostomia, analyze the role of salivary cytokines as biomarkers of xerostomia and assess the possible changes in salivary cytokines following treatment. Materials and methods: A randomized, controlled double-blind clinical study was carried out in 73 patients with xerostomia divided into two groups: placebo and active treatment (cymenol; tocopheryl acetate; D-panthenol; Aloe barbadensis; citrate tribasic dihydrate; fluoride) with oral gel and toothpaste three times a day for four consecutive weeks. The Thomson Xerostomia Inventory was applied, with the assessment of oral quality of life (OHIP-14) at baseline and after four weeks of application of the product. Sialometry was also performed in both groups, with analysis of the IL-1b, IL-6, IL-8 and TNFa levels in saliva. Results: In the active treatment group, the xerostomia scores decreased significantly at the end of the study versus baseline, from 33.47 to 27.93 (p < 0.001). No significant decrease was recorded in the placebo group (34.5 to 32.75; p = 0.190). There were no adverse effects in either group. Regarding the saliva samples, the active treatment group showed significant differences in IL-6 concentration versus the control group (18.55 pg/mL (8–38.28) and 5.83 pg/mL (1.19–12.04), respectively; p = 0.002). No significant differences in salivary cytokines were observed in either the treatment group or the control group. Conclusions: The use of a new toothpaste and gel developed for patients with xerostomia proved effective, with greater symptom relief than in the placebo group. Further clinical studies involving longer time periods and larger samples are advisable in order to confirm the benefits of the described treatment.

Short-term anti-plaque effect of a cymenol mouthwash analysed using the DenTiUS Deep Plaque software: a randomised clinical trial

“…Similarly, some in vivo investigations have evaluated aspects unrelated to the anti-plaque activity of cymenol, such as its ability to reduce xerostomia [ 29 ] and control oral malodour [ 31 ]. Other studies have analysed its substantivity up to four hours after application [ 30 ] and its ability to reduce gingival bleeding in patients with gingivitis [ 27 ], albeit without recording any clinical measurements of dental plaque.…”

Diagnosis, Prevention, and Treatment of Radiotherapy-Induced Xerostomia: A Review

“…Saliva substitutes are one of the most effective measures to relieve xerostomia caused by RT and have antibacterial and preventive effects on tooth demineralization. However, they can only be retained for a short time in the oral cavity and may trigger allergic reactions in patients [ 109 – 112 ]. An edible saliva substitute like oral moisturizing jelly is noteworthy because it contains buffering agents, has a neutral pH, and can improve the swallowing ability of patients, in addition to relieving xerostomia.…”