Vergleichende, randomisierte, kontrollierte und doppelblinde In-situ-Studie zur Wirkung von Speichelersatzmitteln auf Schmelz und Dentin - In-situ-Studie Speichelersatz

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005451-23-DE

Enrollment

Registered

2009-01-26

Start date

2009-05-27

Completion date

Unknown

Last updated

2021-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xerostomia and substantial relief of the symptoms by saliva substitutes

Interventions

Trade Name: Glandosane Product Name: Glandosane Pharmaceutical Form: Oral solution Trade Name: Saliva natura Product Name: Saliva Natura Pharmaceutical Form: Oral solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Stimulated salivary flow rate =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Stimulated salivary flow rate > 0.5 ml/min Missing partial denture upper or lower jaw Missing Radiation Therapie in the head and neck area Parabenallergy Not Signed informend consent (AMG §40 (1) 3b)

Design outcomes

Primary

Measure	Time frame
Main Objective: After in situ exposition the enamel and dentin samples will remineralize with Saliva natura and demineralize with Glandosane.;Secondary Objective: Secondary objectives: The patient will receive a better oral comfort after use of Saliva natura compared to Glandosane;Primary end point(s): E.5 END POINT(S) : E.5.1 Primary End Point (repeat as necessary)25: 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. E.5.1.1 Timepoint(s) of evaluation of this endpoint: after 15 weeks E.5.2 Secondary End Point (repeat as necessary): Evaluation of the general and oral well being before and after therapy by questionnaires. E.5.2.1 Timepoint(s) of evaluation of this endpoint: after 15 weeks	—

Measure

Time frame

Main Objective: After in situ exposition the enamel and dentin samples will remineralize with Saliva natura and demineralize with Glandosane.;Secondary Objective: Secondary objectives: The patient will receive a better oral comfort after use of Saliva natura compared to Glandosane;Primary end point(s): E.5 END POINT(S) : E.5.1 Primary End Point (repeat as necessary)25: 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. E.5.1.1 Timepoint(s) of evaluation of this endpoint: after 15 weeks E.5.2 Secondary End Point (repeat as necessary): Evaluation of the general and oral well being before and after therapy by questionnaires. E.5.2.1 Timepoint(s) of evaluation of this endpoint: after 15 weeks

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026