Dental Caries
Conditions
Keywords
Dental caries, Curodont Repair, P11-4
Brief summary
The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to fluoride.
Detailed description
All study participants must have two early approximal carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). One lesion will be treated with Curodont Repair and one with fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is used.
Interventions
DEVICECurodont Repair
Self-assembling peptide, biomimetic re-mineralisation Application on Day 0 and Day 360
DEVICEFluoride
Application on Day 0, Day 180, Day 360, Day 540
Sponsors
Credentis AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Two approximal carious lesions on different teeth with at least one tooth in between 2. Both study lesions must not require an invasive treatment 3. Size and form of the lesions: the lesions must be fully visible and assessable on radiographs 4. The two carious lesions must fall into classes: * D2 (inner half of enamel) * D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction) 5. Able and willing to observe good oral hygiene throughout the study 6. Age ≥ 18 years and ≤ 65 years 7. Willing and able to attend the on-study visits 8. Willing and able to understand all study-related procedures 9. Written informed consent before participation in the study
Exclusion criteria
1. The two study test lesions are located on adjacent teeth 2. Fluoride varnish application \< 3 months prior to study treatment 3. Tooth with numerous carious lesions 4. Evidence of tooth erosion 5. History of head and neck illnesses (e.g. head/neck cancer) 6. Any pathology or concomitant medication affecting salivary flow or dry mouth 7. Any metabolic disorders affecting bone turnover 8. Patient suffers from diabetes 9. Concurrent participation in another clinical trial 10. Women who are breast-feeding, pregnant or who plan a pregnancy during the study 11. Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opaqueness on X-Ray | Day 360 | The primary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 0 to Day 365 between test and control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Additional benefit of a second Curodont Repair application | Day 720 | The secondary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 360 to Day 720 between test and control group. |
Countries
Switzerland
Outcome results
None listed