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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Dental Caries

Intervention / Treatment
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* Device: Curodont Repair
* Other: Placebo
* Device: Fluoride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curodont Repair<br>Single application of Curodont Repair on treatment day D0 followed by a single application of fluoride (Duraphat) on D90. | Device: Curodont Repair<br>* Self-assembling peptide, biomimetic re-mineralisation<br>* Other names: P11-4;Device: Fluoride<br>* Single application on day D90<br>|
| Placebo Comparator: Placebo<br>Single application of Placebo on treatment day D0 followed by a single application of fluoride (Duraphat) on D90. | Other: Placebo<br>* Formulation of Curodont Repair without the peptide P11-4<br>Device: Fluoride<br>* Single application on day D90<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental caries, Curodont Repair, P11-4