Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions

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.

Inclusion criteria

• Two approximal carious lesions on different teeth with at least one tooth in between
• Both study lesions must not require an invasive treatment
• Size and form of the lesions: the lesions must be fully visible and assessable on radiographs
• 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)
• Able and willing to observe good oral hygiene throughout the study
• Age ≥ 18 years 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

Exclusion criteria

• The two study test lesions are located on adjacent teeth
• Fluoride varnish application < 3 months prior to study treatment
• Tooth with numerous carious lesions
• Evidence of tooth erosion
• 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
• Patient suffers from diabetes
• Concurrent participation in another clinical trial
• Women who are breast-feeding, pregnant or who plan a pregnancy during the study
• 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