Clinical trial NCT03780270: Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization
Official title: Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Decay
Lead sponsor: University Dentistry Clinical Center of Kosovo
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group
timeFrame: Day 180
Secondary outcomes:
measure: Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group
timeFrame: Day 90 and Day 360
measure: Frequency of change in ICDAS-II (International caries detection and assessment system) codes for each study group
timeFrame: Day 90, Day 180, Day 360
measure: Frequency of change in caries lesion activity and severity assessed by Nyvad criteria for each study group
timeFrame: Day 90, Day 180, Day 360
measure: Mean of VAS values (Visual analogue scale) for each study group
timeFrame: Day 90, Day 180, Day 360
measure: Frequency of Evaluation Outcome of Global Impression of Change Questionnaire for each study group
timeFrame: Day 90, Day 180, Day 360
Other outcomes:
Locations:
Study officials:
affiliation: University Dentistry Clinical Center of Kosovo
name: Dafina Doberdoli, Dr.
role: PRINCIPAL_INVESTIGATOR
References: