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

Not Applicable

• Conditions: K02.0; Caries limited to enamel

• Registration Number: DRKS00006215
• Lead Sponsor: Medizinisches Zentrum für ZaMK, Abteilung für Kinderzahnheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-04
• Study Completion: 2015-07-15
• Results First Posted: 2019-01-22
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 9

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Endpoint each arm: 4 weeks after wearing the appliance with specimen.<br>Endpoint of the study: due to the crossover design 12 weeks.<br>Measuring method: surface texture of specimen measured by scanning electron microscopy<br><br>