Goal

To identify in patients with dry mouth the effects of a novel test agent (Oral Essentials Hydrating Formula Mouthwash, Beverly Hills, CA) versus a control agent (Biotène Dry Mouth Oral Rinse, GlaxoSmithKline Consumer Healthcare L.P., Moon Township, PA, USA) versus no treatment on dry mouth, plaque, salivary pH and buffering capacity, gingival health, and tooth sensitivity.

Materials and methods

In this cross-over study, ten subjects with dry mouth used test and control dry mouth interventions, as well as no dry mouth intervention in randomized sequence. Plaque Index, Gingival Index, Sulcus Bleeding Index, Plaque staining, and photographs were recorded at baseline and end of each study arm. Salivary volume, pH, and buffering capacity were also recorded at these time points. Additionally, subjects completed a questionnaire for dry mouth and dentinal sensitivity at each visit.

Results

Reductions in plaque presence and clinical indices were similar after use of test or control products (p < 0.05). Saliva volume and pH buffering improved significantly after use of test and control products (p < 0.05).

Conclusions

The effects of a novel dry mouth intervention are similar to those of an existing OTC remedy and are significantly better than no intervention.

Background

The goal of this study was to identify the in vivo effects in patients with hyposalivation of a novel slowly dissolving adhering test disc upon on enamel remineralization, oral biofilm, salivary production, pH and buffering, gingival health, and on self-evaluation of oral well-being.

Methods

Five subjects with xerostomia wore custom made retainers carrying 5 demineralized enamel chips for periods of 1 week each. In 1 study arm, subjects used the test agent plus oral hygiene self-care; in the other they used oral hygiene self-care only, with a 1 week washout in between arms. The treatment sequence was randomized. Before and after each study arm Plaque Index (PI), Gingival Index (GI) and Sulcus Bleeding Index (mSBI) were recorded. Clinical plaque staining was quantified using digital image analysis. Saliva production, pH and buffering capacity were recorded. Subjects completed a self-evaluation questionnaire for oral comfort. Enamel samples underwent standardized Knoop microhardness testing to quantify mineralization status.

Results

Plaque presence and clinical Plaque Indices decreased significantly with test agent use (p<0.05). Five-minute saliva production almost doubled 10 and 40 minutes after oral test disc insertion (significant, p<0.05). Salivary pH buffering improved in 4/5 subjects with disc use. All demineralized tooth samples re-hardened intraorally (p>0.05). The discs favorably impacted eating problems and dental sensitivity. Subjects were positive about disc flavor and mouth feel.

Conclusion

Using established in vivo techniques, the effects of a novel product in xerostomic patients were evaluated and quantified. The adhering disc facilitated eating, reduced dental sensitivity, improved saliva production and buffering capacity, reduced plaque, and alleviated xerostomia symptoms.

Clinical relevance

Xerostomia management is challenging. A novel dry mouth disc was effective in alleviating dry mouth symptoms.