Effect of Curodont™ Repair in Patients With Early Approximal 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 approximal carious lesions compared to fluoride.

Detailed Description
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All study participants must have two early approximal 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 fluoride as control. Study duration is 24 months. For assessment x-ray pictures, Diagnodent Pen and DiagnoCam is used.

Official Title
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Effect of Curodont™ Repair in Patients With Early Approximal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised, Split-mouth, Post-marketing Study

Conditions
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Dental Caries

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Two approximal carious lesions on different teeth with at least one tooth in between Both study lesions must not require an invasive treatment Size and form of the lesions: the lesions must be fully visible and assessable on radiographs The two carious lesions must fall into classes: D2 (inner half of enamel) D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction) Able and willing to observe good oral hygiene throughout the study Age ≥ 18 years 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 Exclusion Criteria: The two study test lesions are located on adjacent teeth Fluoride varnish application < 3 months prior to study treatment Tooth with numerous carious lesions Evidence of tooth erosion 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 Patient suffers from diabetes Concurrent participation in another clinical trial Women who are breast-feeding, pregnant or who plan a pregnancy during the study Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curodont Repair<br>Application on Day 0 and Day 360 | Device: Curodont Repair<br>* Self-assembling peptide, biomimetic re-mineralisation Application on Day 0 and Day 360<br>* Other names: P11-4;|
| Active Comparator: Fluoride<br>Application on Day 0, Day 180, Day 360, Day 540 | Device: Fluoride<br>* Application on Day 0, Day 180, Day 360, Day 540<br>* Other names: Duraphat;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opaqueness on X-Ray | The primary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 0 to Day 365 between test and control group. | Day 360 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional benefit of a second Curodont Repair application | The secondary efficacy outcome is the difference of the change in the opaqueness of the carious lesion on the x-ray picture from Day 360 to Day 720 between test and control group. | Day 720 | 

 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