NCT02724592

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

Effect of Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

Summary

Objectives: Occlusal surfaces of erupting permanent molars are highly 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 (Duraphat®) groups.

Detailed description

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 (Duraphat®) groups. Safety and applicability will be evaluated using dentist's/patient's questionnaires about adverse events, difficulties of application and satisfaction with procedure. Lesions will be assessed at baseline and recalls after 3 and 6 months regarding caries activity, clinical status (ICDAS-II) and with Diagnodent®. The Visual Analog Scale (VAS) of regression and of lesion size in addition to the Global Impression of Change Questionnaire will also be assessed. At every recall, fluoride varnish will be applied on lesions and patients received oral health instructions.

Conditions

• Dental Caries

Interventions

Type	Name	Description
DEVICE	self assembling peptide P11-4 (Curodont™ Repair)	Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions
DEVICE	fluoride varnish (Duraphat®)	Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-04-01
• Completion: 2014-10-01
• First posted: 2016-03-31
• Last updated: 2021-04-08
• Results posted: 2021-04-08