Effect of Saliva Substitutes on Dental Hard Tissues in Situ (T-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01165970
Recruitment Status : Terminated
First Posted : July 20, 2010
Last Update Posted : November 15, 2011
Information provided by (Responsible Party):
Peter Tschoppe, Charite University, Berlin, Germany

June 30, 2010
July 20, 2010
November 15, 2011
January 2009
March 2012   (Final data collection date for primary outcome measure)
Mineral loss and lesion depth of specimens [ Time Frame: 15 weeks ]
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.
Same as current
Complete list of historical versions of study NCT01165970 on Archive Site
general and oral well being [ Time Frame: 15 weeks ]
Evaluation of the general and oral well being before and after therapy by questionnaires.
Same as current
Not Provided
Not Provided
Effect of Saliva Substitutes on Dental Hard Tissues in Situ
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
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Drug: Glandosane
    according to the german law the sued saliva substitute is a drug (Glandosane) whereas Saliva natura is a medical product
    Other Name: Glandosane, Cell Pharm, Germany
  • Device: Saliva natura
    Saliva substitute without restriction to be used
    Other Name: Saliva natura, Medac, Germany
  • Active Comparator: Glandosane
    After in situ exposition the enamel and dentin samples will demineralize with Glandosane.
    Intervention: Drug: Glandosane
  • Experimental: Saliva natura
    After in situ exposition the enamel and dentin samples will remineralize with Saliva natura
    Intervention: Device: Saliva natura
Tschoppe P, Wolf O, Eichhorn M, Martus P, Kielbassa AM. Design of a randomized controlled double-blind crossover clinical trial to assess the effects of saliva substitutes on bovine enamel and dentin in situ. BMC Oral Health. 2011 Apr 9;11:13. doi: 10.1186/1472-6831-11-13.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2012
March 2012   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
2008-005451-23 ( EudraCT Number )
Not Provided
Not Provided
Peter Tschoppe, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Peter Tschoppe, Dr Department of Operative Dentistry and Periodontology, School of Dental Medicine, CharitéCentrum 3, Charité - Universitätsmedizin Berlin
Charite University, Berlin, Germany
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP