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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 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 (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.


Sponsor: University Medicine Greifswald

Current Primary Outcome: ICDAS (International Caries Detection and Assessment System) index, caries activity assessment according to Nyvad criteria and LASER fluorescence readings using Diagnodent® device. [ Time Frame: 6 months ]

Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using ICDAS caries index, caries activity assessment according to Nyvad criteria and LASER fluorescence readings using Diagnodent® device.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of Treatment-Emergent Adverse Events (definitions are adapted from Directive 2001/20/EC and in accordance with ISO 14155 and MDD 93/42). [ Time Frame: 6 months ]
    Safety definitions are adapted from the Directive 2001/20/EC and in accordance with ISO 14155 and MDD 93/42.
  • clinical applicability [ Time Frame: 6 months ]
    clinical applicability was investigated using dentist's questionnaire.
  • patient satisfaction [ Time Frame: 6 months ]
    patient satisfaction was investigated using patient's questionnaire.


Original Secondary Outcome: Same as current

Information By: University Medicine Greifswald

Dates:
Date Received: March 7, 2016
Date Started: February 2013
Date Completion:
Last Updated: March 24, 2016
Last Verified: March 2016