Status:
TERMINATED
Effect of Saliva Substitutes on Dental Hard Tissues in Situ
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Hyposalivation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 radiother...
Detailed Description
see application for the German Federal Institute for Drugs and Medical Devices at Eudra-CT
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01165970
Start Date
January 1 2009
End Date
December 1 2012
Last Update
November 15 2011
Active Locations (2)
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1
Charite, Berlin, Germany
Berlin, State of Berlin, Germany, 14197
2
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 14197