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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Credentis AG
Sponsor:
Collaborator:
Swiss Commission for Technology and Innovation CTI
Information provided by (Responsible Party):
Credentis AG
ClinicalTrials.gov Identifier:
NCT02020681
First received: December 19, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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 Intervention
Dental Caries
Device: Curodont Repair
Other: Placebo
Device: Fluoride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Credentis AG:

Primary Outcome Measures:
  • 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. [ Time Frame: D0, D30, D90, D270 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in the change of ECM values between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D180, D270 ] [ Designated as safety issue: No ]
  • Difference in the change of Diagnodent Pen values between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D180, D270 ] [ Designated as safety issue: No ]
  • Difference in the change of Canary System values between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D180, D270 ] [ Designated as safety issue: No ]
  • Change in lesion's progression assessed by VAS between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D180, D270 ] [ Designated as safety issue: No ]
  • Cavitation rate between investigational medical device and placebo group. [ Time Frame: D0, D30, D90, D180, D270 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   14 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02020681

Contacts
Contact: Ivo Krejci, Prof. Dr. +41 223794101 Ivo.Krejci@unige.ch

Locations
Switzerland
University of Geneva - Devision of Cariology and Endodontology Recruiting
Geneva, Switzerland, 1205
Contact: Ivo Krejci, Prof. Dr.    +41 223794101    Ivo.Krejci@unige.ch   
Contact: Alaa Mannaa, Dr.    +41 223794101    Alaa.Mannaa@unige.ch   
Principal Investigator: Ivo Krejci, Prof. Dr.         
Sub-Investigator: Alaa Mannaa, Dr.         
Sponsors and Collaborators
Credentis AG
Swiss Commission for Technology and Innovation CTI
Investigators
Principal Investigator: Ivo Krejci, Prof. Dr. University of Geneva
  More Information

Publications:
Responsible Party: Credentis AG
ClinicalTrials.gov Identifier: NCT02020681     History of Changes
Other Study ID Numbers: P11-4-CURAF, 14934.1 PFLS-LS
Study First Received: December 19, 2013
Last Updated: December 19, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Credentis AG:
Dental caries
Curodont Repair
P11-4

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2014