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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Peter Tschoppe, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01165970
First received: June 30, 2010
Last updated: November 12, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Hyposalivation
Drug: Glandosane
Device: Saliva natura
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vergleichende, Randomisierte, Kontrollierte Und Doppelblinde In-situ-Studie Zur Wirkung Von Speichelersatzmitteln Auf Schmelz Und Dentin

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Mineral loss and lesion depth of specimens [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • general and oral well being [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    Evaluation of the general and oral well being before and after therapy by questionnaires.


Enrollment: 19
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glandosane
After in situ exposition the enamel and dentin samples will demineralize with Glandosane.
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
Experimental: Saliva natura
After in situ exposition the enamel and dentin samples will remineralize with Saliva natura
Device: Saliva natura
Saliva substitute without restriction to be used
Other Name: Saliva natura, Medac, Germany

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01165970

Locations
Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 14197
Charite, Berlin, Germany
Berlin, Germany, 14197
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Peter Tschoppe, Dr Department of Operative Dentistry and Periodontology, School of Dental Medicine, CharitéCentrum 3, Charité - Universitätsmedizin Berlin
  More Information

Additional Information:
No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Tschoppe, Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01165970     History of Changes
Other Study ID Numbers: T-01/2008-005451-23, 2008-005451-23
Study First Received: June 30, 2010
Last Updated: November 12, 2011
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
enamel
dentin
saliva substitute
demineralization
remineralization

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 26, 2014