Abstract
Objective: This multicenter clinical study was to assess the clinical usability of an oral moisture-checking device in detecting the dry mouth patients and evaluating the optimal measurement site. Materials and Methods: The study group comprised 250 patients with dry mouth and 241 healthy volunteer subjects at 13 medical centers. This device was used to measure the moisture degrees of the lingual mucosa and the buccal mucosa. Subjective oral dryness, objective oral dryness, and saliva flow rates were also compared between the two groups. For statistical analysis, receiver-operating characteristic analysis was performed to calculate the area under the curve (AUC). Results: The moisture degree of the lingual mucosa was significantly lower in the dry mouth group (27.2 ± 4.9) than that in the healthy group (29.5 ± 3.1, AUC = 0.653). When a lingual mucosa moisture degree of 31.0 or higher was defined as normal, less than 27.0 as dry mouth, and 27.0 to less than 31.0 as borderline zone of dry mouth, both the sensitivity and the specificity for the diagnosis of dry mouth were close to 80%. Conclusion: These results suggest that the oral moisture-checking device is a usable screening device for dry mouth.
Highlights
Oral dryness is objectively evaluated by examinations of salivary flow rates by techniques of stimulated whole salivary collection (SWSC) such as the OPEN ACCESSY
We examined the following variables: oral moisture degree according to measurement site, participating medical centers, cut-off values according to measurement sites, correlations of oral mucosal dryness with other measured variables, and the presence or absence of adverse events at the time of measurement of oral moisture degree
Oral moisture degree of the lingual mucosa was significantly lower in the dry mouth group (27.2 ± 4.9 [mean ± standard deviation]) than in the healthy group (29.5 ± 3.1, p < 0.001)
Summary
Oral dryness is objectively evaluated by examinations of salivary flow rates by techniques of stimulated whole salivary collection (SWSC) such as the OPEN ACCESSY. Fukushima et al / Open Journal of Stomatology 3 (2013) 440-446 chewing gum test and the Saxon test or unstimulated whole salivary collection (UWSC) such as spitting method, or by assessing salivary gland secretory function by salivary gland scintigraphy These methods indirectly estimate oral dryness on the basis of the salivary flow rate and salivary gland function, but do not evaluate oral mucosal dryness (moisture degree) directly. An oral moisture-checking device has been developed recently by adapting a skin moisture sensor suitable for oral mucosa. The moisture contents of the tongue and buccal mucosa are usually measured, the optimal site for measurement remains unclear The purpose of this multicenter clinical study is to assess the clinical usability of an oral moisture-checking device in detecting the dry mouth patients and evaluating the optimal measurement site
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