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

University Dentistry Clinical Center of Kosovo

Status: Completed

Conditions: Tooth Decay

Treatments: Device: Fluoride Varnish; Device: Curodont Repair; Device: Curodont Protect

Study type: Interventional

Funder types: Other

Identifiers

NCT03780270

500

Details and patient eligibility

About

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

Full description

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.

Enrollment: 90 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Control

Active Comparator group

Description:

Fluoride Varnish (Fluor Protector S; Ivoclar, 7'700 ppm F-) application at Day 0 and Day180. =\> Group: Fluoride Varnish

Treatment:

Device: Fluoride Varnish

Test1

Experimental group

Description:

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

Treatment:

Device: Curodont Repair

Device: Fluoride Varnish

Test2

Experimental group

Description:

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

Treatment:

Device: Curodont Repair

Device: Curodont Protect