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Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions

Sponsor
Credentis AG (Industry)
Overall Status
Completed
CT.gov ID
NCT02020681
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
28
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early buccal carious lesions compared to placebo.

Condition or Disease Intervention/Treatment Phase
  • Device: Curodont Repair
  • Other: Placebo
  • Device: Fluoride
 N/A

Detailed Description

All study participants must have two early class V 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 one with placebo as control (single application). 3 months later fluoride (Duraphat) will be applied on both lesions. Study duration is 9 months. For assessment visual and tactile evaluation, pictures, ECM, Diagnodent Pen, Canary System, VAS is used.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Curodont Repair or Placebo on the Remineralisation in Patients With Class 5 Carious Lesions: A Mono-centre, Split-mouth, Double-blinded, Placebo Controlled, Randomised, Post Marketing Clinical Study
Study Start Date :
Sep 1, 2013
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Curodont Repair

Single application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.

Device: Curodont Repair
Self-assembling peptide, biomimetic re-mineralisation
Other Names:
  • P11-4

    • Device: Fluoride
    Single application on day D90
    Placebo Comparator: Placebo

    Single application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90.

    Other: Placebo
    Formulation of Curodont Repair without the peptide P11-4

    Device: Fluoride
    Single application on day D90

    Outcome Measures

    Primary Outcome Measures

    1. The primary efficacy outcome is the difference of the change in the lesion size assessed by morphometry (standardised pictures) between investigational medical device and placebo group. [D0, D30, D90, D270]

      Change of lesion size relative to baseline between study groups and different time points

    Secondary Outcome Measures

    1. Difference in the change of Diagnodent Pen values between investigational medical device and placebo group. [D0, D30, D90, D180, D270]

      only descriptively analysed

    2. Change in lesion's progression assessed by VAS between investigational medical device and placebo group. [D0, D30, D90, D180, D270]

      only descriptively analysed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Two class V carious lesions which do not require an invasive treatment

    • Size and form of the lesions: the lesions must both be fully visible and assessable and accessible

    • Patients must be able and willing to observe good oral hygiene throughout the study

    -≥ 20 teeth

    • Permanent dentition 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

    • Negative pregnancy test for women of childbearing potential

    Exclusion Criteria:

    • The two study lesions must not be on adjacent teeth

    • No adjacent restoration on study tooth surface

    • Fluoride varnish application < 6 months prior to study treatment

    • Patient suffers from diabetes

    • Evidence of tooth erosion (due to excessive acidic drink consumption or reflux)

    • 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 with an investigational drug or device or participation in another clinical trial with an investigational drug or device within 30 days prior to study entry

    • Pregnant and lactating woman

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Geneva - Devision of Cariology and Endodontology Geneva Switzerland 1205

    Sponsors and Collaborators

    • Credentis AG

    Investigators

    • Principal Investigator: Ivo Krejci, Prof. Dr., University of Geneva

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Credentis AG
    ClinicalTrials.gov Identifier:
    NCT02020681
    Other Study ID Numbers:
    • P11-4-CURAF
    • 14934.1 PFLS-LS
    First Posted:
    Dec 25, 2013
    Last Update Posted:
    Aug 30, 2019
    Last Verified:
    Aug 1, 2019
    Keywords provided by Credentis AG
    Dental caries
    Curodont Repair
    P11-4
    Additional relevant MeSH terms:
    Dental Caries
    Fluorides

    Study Results

    No Results Posted as of Aug 30, 2019