Xerostomia and prevention of dryness with a Pycnogenol® mouth spray: a pilot study.

Background: The aim of this pilot, supplement study was the evaluation of primary, idiopathic mucosal mouth dryness (xerostomia or dry mouth) in subjects without systemic diseases.

Methods: Subjects with xerostomia were managed either with standard management (SM) or with SM and a Pycnogenol mouth spray (Hankintatukku Oy, Karkkila, Finland), at the dosage of 60 mg/day in 30 spurts, for 2 weeks.

Results: A total of 50 subjects were included in the study: 25 controls using only standard management (SM) and 25 subjects using the Pycnogenol mouth spray. No side effects and no tolerability problems were observed with the Pycnogenol mouth spray. The groups were comparable for characteristics and symptoms at baseline. These otherwise healthy subjects had a BMI<26. After 2 weeks, salivary flow and salivary oxidative stress (in Carr Units) were improved significantly with Pycnogenol mouth spray as compared to controls (P<0.05), whereas minimal improvements in salivary flow were seen with SM. The subjective symptomatic dry mouth score and the number of mucosal breaks and ulcerations (all minimal, <1 mm in length or diameter) were significantly decreased with the Pycnogenol mouth spray supplement compared to SM controls (P<0.05). The Pycnogenol mouth spray led to significant improvement in salivary lysozyme levels, compared to controls (P<0.05).

Conclusions: Based on these preliminary results, Pycnogenol mouth spray could be a new supplementary option for the management of primary xerostomia.