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

NCT02724592 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-04-08

Study results available
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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.

Conditions

  • Dental Caries

Interventions

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

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Mohammad Alkilzy, Dr. PhD · University of Greifswald

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-04-30
Completion
2014-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02724592 on ClinicalTrials.gov