Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions

Launched by UNIVERSITY MEDICINE GREIFSWALD · Mar 24, 2016

Keywords

ClinConnect Summary

Objectives: Occlusal surfaces of erupting permanent molars are high prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.

Methods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Dur...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Early occlusal carious lesions (without cavity) on permanent molar "6" or "7" at eruption which does not require an invasive treatment
• • Age ≥ 5 years
• • Size and form of the lesions: the lesions must both be fully visible and assessable and accessible
• • Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study
• • Written informed consent before participation in the study
• Exclusion Criteria:
• • Evidence of tooth erosion
• • Fluoride varnish application \< 3 months prior to study treatment
• • 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