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

University Dentistry Clinical Center of Kosovo90 enrolled

Overview

The purpose of this study is to evaluate 1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone 2. the tooth gel Curodont Protect when using it after Curodont Repair instead of fluoride varnish

Objectives: The purpose of this study is to evaluate 1. the additional therapeutic benefit of Curodont Repair for the treatment early occlusal carious lesions on permanent teeth in children compared fluoride varnish alone 2. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tooth Decay

Interventions

Fluoride VarnishDEVICE

Fluor Protector S (Ivoclar, 7'700 ppm F-)

Curodont RepairDEVICE

P11-4 (monomeric peptide) - for professional use

Curodont ProtectDEVICE

Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)

Eligibility

Sex: ALLMin age: 6 YearsMax age: 15 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Day 180

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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)

Data from ClinicalTrials.gov

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