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

Launched by CREDENTIS AG · Mar 28, 2014

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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