Hyposalivation Clinical Trial
Official title:
Vergleichende, Randomisierte, Kontrollierte Und Doppelblinde In-situ-Studie Zur Wirkung Von Speichelersatzmitteln Auf Schmelz Und Dentin
Symptomatic hyposalivation is associated not only with Sjögren`s syndrome or salivary gland
hypofunction in elderly patients, but also with medications containing antimuscarinic drugs,
chemo radiotherapy for head and neck carcinomas, and psychiatric disorders (Atkinson & Ava,
1994, Kielbassa et al., 2006).
Human saliva possesses important physiological functions in protecting and moistening the
oral hard and soft tissues (Piotrowski et al., 1992, ). Consequently, decreasing salivation
causes oral dysfunction and promotes severe oral side effects (reduced antibacterial
function, lack of remineralisation, reduced buffer capacity) (Tschoppe et al., 2010a). These
have been identified as being responsible for the rapid destruction of the dentition
(Willich et al., 1988). Saliva substitutes are frequently applied for relieving the symptoms
in patients suffering from hyposalivation (Hahnel et al., 2009, Nieuw Amerongen & Veerman,
2003, Vissink et al., 2004). Besides the moistening and lubrication of the oral mucosa,
these products should also protect dental hard tissues. However, in vitro studies revealed
that some marketed products have only a neutral or even a demineralising potential on enamel
as well as on dentin (Kielbassa et al., 2001, Meyer-Lueckel et al., 2002, Smith et al.,
2001, Tschoppe et al., 2009). Inorganic ions such as calcium, phosphates, and fluorides have
been added to saliva substitutes in order to enhance their remineralising property or
minimize their demineralising potential (Tschoppe et al., 2009). Furthermore, as most
patients suffering from hyposalivation are elderly people, recessions and subsequently
exposed dentin surfaces are very common. Since dentin is not as acid resistant as enamel, an
earlier and more severe demineralisation can be expected (Saunders & Meyerowitz, 2005).
Therefore, the current in situ study was performed to assess the effects of a demineralising
and a remineralising saliva substitutes on the mineralisation of dental hard tissues. It was
hypothesized that storage in Glandosane(cell pharm, Hannover, Germany) would not result in
pronounced mineral loss of dentin specimens, and that storage in Saliva natura would not
result in enhanced remineralisation when combined with a remineralising artificial saliva
(Saliva natura supersaturated with respect to relevant calcium phosphates; medac, Hamburg,
Germany) (H0). These null hypotheses were tested against the alternative hypothesis of a
difference.
see application for the German Federal Institute for Drugs and Medical Devices at Eudra-CT ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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