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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Device: Curodont Repair; Device: Fluoride; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • University of Geneva - Devision of Cariology and Endodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Device: Fluoride; Single application on day D90; Other: Placebo; Formulation of Curodont Repair without the peptide P11-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change of lesion size relative to baseline between study groups and different time points	D0, D30, D90, D270

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the change of Diagnodent Pen values between investigational medical device and placebo group.	only descriptively analysed	D0, D30, D90, D180, D270
Change in lesion's progression assessed by VAS between investigational medical device and placebo group.	only descriptively analysed	D0, D30, D90, D180, D270

Collaborators and Investigators

• Sponsor: Credentis AG
• Investigators: Principal Investigator: Ivo Krejci, Prof. Dr., University of Genova

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (Estimate): December 25, 2013

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Dental caries; Curodont Repair; P11-4
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: P11-4-CURAF; 14934.1 PFLS-LS (Other Grant/Funding Number: Swiss Committee for Technology and Innovation KTI)