Effect of Saliva Substitutes on Dental Hard Tissues in Situ

Hyposalivation Clinical Trial

— T-01  

Official title:

Vergleichende, Randomisierte, Kontrollierte Und Doppelblinde In-situ-Studie Zur Wirkung Von Speichelersatzmitteln Auf Schmelz Und Dentin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01165970
• Other study ID #: T-01/2008-005451-23
• Secondary ID: 2008-005451-23
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 30, 2010
• Last updated: November 12, 2011
• Start date: January 2009
• Est. completion date: December 2012

Study information

• Verified date: November 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Food, Agriculture and Consumer ProtectionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Description:

see application for the German Federal Institute for Drugs and Medical Devices at Eudra-CT

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• stimulated salivary flow rate < 0.5 ml/min

• partial denture upper or lower jaw

• radiationtherapy in the head and neck area

• patient age above 18 years

• Signed informed consent (AMG §40 (1) 3b)

Exclusion Criteria:

• stimulated salivary flow rate > 0.5 ml/min

• missing partial denture upper or lower jaw

• missing Radiationtherapy in the head and neck area

• paraben allergy

• not signed informed consent (AMG §40 (1) 3b)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyposalivation

Intervention

Drug:
• Glandosane
according to the german law the sued saliva substitute is a drug (Glandosane) whereas Saliva natura is a medical product

Device:
• Saliva natura
Saliva substitute without restriction to be used

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Charite, Berlin, Germany	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mineral loss and lesion depth of specimens	Evaluation of the mineral loss/lesion depth of the enamel and dentin specimens after in situ exposition evaluated with transversal microradiography. The Unit is the mineral oss as well as lesion depth.	15 weeks	No
Secondary	general and oral well being	Evaluation of the general and oral well being before and after therapy by questionnaires.	15 weeks	No

External Links

•   please check the science subsite
•   Short review on the main problems in this patient population: Etiologic factors of hyposalivation and consequences for oral health. Quintessence Int. 2010 Apr;41(4):321-33. Review.