Trials / Completed
CompletedNCT03780270
Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- University Dentistry Clinical Center of Kosovo · Academic / Other
- Sex
- All
- Age
- 6 Years – 15 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate 1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone 2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish
Detailed description
Objectives: The purpose of this study is to evaluate 1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone 2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish Methods: 90 patients with early occlusal lesions (ICDAS-II:2-3) on permanent molars and pre-molars will be allocated in this randomized, controlled, single blinded study to one of the two test groups (Test1: Curodont™ Repair+Fluoride Varnish; Test2: Curodont Repair+Curodont Protect) or control (Fluoride Varnish) group. Lesions will be assessed at baseline and recalls after 3, 6 and 12 months regarding caries activity (Nyvad), clinical status (ICDAS-II) and with Diagnodent®. Visual Analog Scale (VAS) in addition to the Global Impression of Change Questionnaire will also be used for the evaluation of the outcome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Fluoride Varnish | Fluor Protector S (Ivoclar, 7'700 ppm F-) |
| DEVICE | Curodont Repair | P11-4 (monomeric peptide) - for professional use |
| DEVICE | Curodont Protect | Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC) |
Timeline
- Start date
- 2014-06-16
- Primary completion
- 2016-12-31
- Completion
- 2016-12-31
- First posted
- 2018-12-19
- Last updated
- 2018-12-19
Source: ClinicalTrials.gov record NCT03780270. Inclusion in this directory is not an endorsement.