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Effect of Curodont TM Protect on prevention of artificial carious lesions of bovine enamel-an in-situ study

Effect of Curodont TM Protect on prevention of artificial carious lesions of bovine enamel-an in-situ study - Preventive effect of Curodont TM Protect

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00006215
Enrollment
9
Registered
2014-06-04
Start date
2014-12-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

K02.0

Interventions

Group 1: Saliva (no intervention, natural saliva in patients´mouth, 4 weeks in total) Group 2: Duraphat-Varnish (1x in 4 weeks, 4 weeks in total) Group 3: Curodont Protect (2x week, 4 weeks in total)

Sponsors

Medizinisches Zentrum für ZaMK, Abteilung für Kinderzahnheilkunde
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age = 18 years low caries activity Willing and able to attend the on-study visits and assessments Willing and able to understand all study-related procedures and to follow the self-treatment instructions informed consent

Exclusion criteria

Exclusion criteria: Subjects with removable partial denture; Subjects with fixed orthodontic appliances; Subjects with current dental trauma or surgery; Last applied high-concentration fluoride treatment (elmexgelee, etc.) < 2 weeks; Smoker; Subjects with bronchial asthma; Evidence of tooth erosion; History of head and neck illnesses (e.g. head/neck cancer); Pregnant and breast-feeding women (no pregnancy test will be done for this clinical in situ study. Patient’s statement is considered as sufficient.); Any pathology or concomitant medication affecting salivary flow or dry mouth: unstimulated < 0.2 ml/min; Last taking of antibiotics < 2 months Patients receiving medication known to stain teeth like tetracycline or chlorhexidine high caries risk; Concurrent participation in another clinical trial; Subjects with known allergies//hypersensitivity towards agent of Curodont Protect or Duraphat varnish respectively.

Design outcomes

Primary

MeasureTime frame
Endpoint each arm: 4 weeks after wearing the appliance with specimen. Endpoint of the study: due to the crossover design 12 weeks. Measuring method: loss of mineral in enamel measured by micro-ct and fluoreszence.

Secondary

MeasureTime frame
Endpoint each arm: 4 weeks after wearing the appliance with specimen. Endpoint of the study: due to the crossover design 12 weeks. Measuring method: surface texture of specimen measured by scanning electron microscopy

Countries

Germany

Contacts

Public ContactAnahita Jablonski-Momeni

Philipps-Universität Marburg, Medizinisches Zentrum für ZMK, Abteilung für Kinderzahnheilkunde

momeni@staff.uni-marburg.de06421-5866527

Outcome results

None listed

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