Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish

Detailed Description
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Objectives: The purpose of this study is to evaluate the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish Methods: 90 patients with early occlusal lesions (ICDAS-II:2-3) on permanent molars and pre-molars will be allocated in this randomized, controlled, single blinded study to one of the two test groups (Test1: Curodont™ Repair+Fluoride Varnish; Test2: Curodont Repair+Curodont Protect) or control (Fluoride Varnish) group. Lesions will be assessed at baseline and recalls after 3, 6 and 12 months regarding caries activity (Nyvad), clinical status (ICDAS-II) and with Diagnodent®. Visual Analog Scale (VAS) in addition to the Global Impression of Change Questionnaire will also be used for the evaluation of the outcome.

Official Title
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Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization

Conditions
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Tooth Decay

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Early occlusal carious lesion which does not require an invasive treatment (ICDAS-II scores: 2 and 3) Size and form of the lesion: the lesion must both be fully visible and assessable and accessible Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study Written informed consent before participation in the study Exclusion Criteria: Evidence of tooth Erosion Fluoride varnish application < 3 months prior to study treatment 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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 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 |
| --- | --- |
| Active Comparator: Control<br>Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180. => Group: Fluoride Varnish | Device: Fluoride Varnish<br>* Fluor Protector S (Ivoclar, 7'700 ppm F-)<br>|
| Experimental: Test1<br>Single application of Curodont Repair (P11-4) at Day 0 followed by a Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application. Another fluoride Varnish application at Day180. => Group: Curodont Repair + Fluoride Varnish | Device: Fluoride Varnish<br>* Fluor Protector S (Ivoclar, 7'700 ppm F-)<br>Device: Curodont Repair<br>* P11-4 (monomeric peptide) - for professional use<br>|
| Experimental: Test2<br>Single application of Curodont Repair (P11-4) at Day 0. Curodont Protect (tooth gel containing P11-4 matrix) is handed out and subjects are asked to apply it 2x weekly at home after regular teeth cleaning in the evening for the whole study period (Day 360). => Group: Curodont Repair + Curodont Protect | Device: Curodont Repair<br>* P11-4 (monomeric peptide) - for professional use<br>Device: Curodont Protect<br>* Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group | Diagnodent values for fissure caries: 0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization. | Day 180 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group | Diagnodent values for fissure caries: 0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization. | Day 90 and Day 360 | 
| Frequency of change in ICDAS-II (International caries detection and assessment system) codes for each study group | Code 0: Sound tooth surface, no evidence of caries after prolonged air drying (5 sec). Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel. Code 3: Localized enamel breakdown due to caries with no visible dentine or underlying shadow. Code 4: Underlying dark shadow from dentine with or without enamel breakdown. Code 5: Distinct cavity with visible dentine. Code 6: Extensive distinct cavity with visible dentine (involving more than half of the dentine). | Day 90, Day 180, Day 360 | 
| Frequency of change in caries lesion activity and severity assessed by Nyvad criteria for each study group | Score 0: Sound. Score 1: Active caries - intact surface. Score 2: Active caries - surface discontinuity. Score 3: Active caries - cavity. Score 4: Inactive caries - intact surface. Score 5: Inactive caries - surface discontinuity. Score 6: Inactive caries - cavity. | Day 90, Day 180, Day 360 | 
| Mean of VAS values (Visual analogue scale) for each study group | Range: from -50 (strongly remineralizing) to +50 (stronlgy progressing) | Day 90, Day 180, Day 360 | 
| Frequency of Evaluation Outcome of Global Impression of Change Questionnaire for each study group | Investigator Questionnaire: evaluation ranging from very much worse to very much better; 7-point scale | Day 90, Day 180, Day 360 |