Effect of Curodont Repair in Patients With Early Approximal Carious Lesions

Launched by CREDENTIS AG · Apr 17, 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 the other will not undergo a treatment as control. Study duration is 12 months. For assessment x-ray pictures are used.

Gender

ALL

Eligibility criteria

• 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:
• • D1 (outer half of enamel) 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