Tooth Decay
Conditions
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.
Interventions
DEVICEFluoride Varnish
Fluor Protector S (Ivoclar, 7'700 ppm F-)
DEVICECurodont Repair
P11-4 (monomeric peptide) - for professional use
DEVICECurodont Protect
Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)
Sponsors
University Dentistry Clinical Center of Kosovo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group | Day 180 | Diagnodent values for fissure caries: 0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean of values measured by Diagnodent(TM) (fluorescence measurement device for carious lesions) for each study group | Day 90 and Day 360 | Diagnodent values for fissure caries: 0-5: no demineralization, sound. 6-14: outer enamel demineralization. 15-20: inner enamel demineralization. 21-99: dentine demineralization. |
| Frequency of change in ICDAS-II (International caries detection and assessment system) codes for each study group | Day 90, Day 180, Day 360 | 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). |
| Frequency of change in caries lesion activity and severity assessed by Nyvad criteria for each study group | Day 90, Day 180, Day 360 | 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. |
| Mean of VAS values (Visual analogue scale) for each study group | Day 90, Day 180, Day 360 | Range: from -50 (strongly remineralizing) to +50 (stronlgy progressing) |
| Frequency of Evaluation Outcome of Global Impression of Change Questionnaire for each study group | Day 90, Day 180, Day 360 | Investigator Questionnaire: evaluation ranging from very much worse to very much better; 7-point scale |
Outcome results
None listed