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 buccal carious lesions compared to placebo.
Detailed description
All study participants must have two early class V 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 placebo as control (single application). 3 months later fluoride (Duraphat) will be applied on both lesions. Study duration is 9 months. For assessment visual and tactile evaluation, pictures, ECM, Diagnodent Pen, Canary System, VAS is used.
Interventions
DEVICECurodont Repair
Self-assembling peptide, biomimetic re-mineralisation
OTHERPlacebo
Formulation of Curodont Repair without the peptide P11-4
DEVICEFluoride
Single application on day D90
Sponsors
Credentis AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Two class V carious lesions which do not require an invasive treatment * Size and form of the lesions: the lesions must both be fully visible and assessable and accessible * Patients must be able and willing to observe good oral hygiene throughout the study -≥ 20 teeth * Permanent dentition and ≤ 65 years * Willing and able to attend the on-study visits * Willing and able to understand all study-related procedures * Written informed consent before participation in the study * Negative pregnancy test for women of childbearing potential
Exclusion criteria
* The two study lesions must not be on adjacent teeth * No adjacent restoration on study tooth surface * Fluoride varnish application \< 6 months prior to study treatment * Patient suffers from diabetes * Evidence of tooth erosion (due to excessive acidic drink consumption or reflux) * History of head and neck illnesses (e.g. head/neck cancer) * Any pathology or concomitant medication affecting salivary flow or dry mouth * Any metabolic disorders affecting bone turnover * Concurrent participation in another clinical trial with an investigational drug or device or participation in another clinical trial with an investigational drug or device within 30 days prior to study entry * Pregnant and lactating woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary efficacy outcome is the difference of the change in the lesion size assessed by morphometry (standardised pictures) between investigational medical device and placebo group. | D0, D30, D90, D270 | Change of lesion size relative to baseline between study groups and different time points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the change of Diagnodent Pen values between investigational medical device and placebo group. | D0, D30, D90, D180, D270 | only descriptively analysed |
| Change in lesion's progression assessed by VAS between investigational medical device and placebo group. | D0, D30, D90, D180, D270 | only descriptively analysed |
Countries
Switzerland
Outcome results
None listed