Tooth Decay Clinical Trial
Official title:
Preventive Treatment Approach of Early Caries Lesions With Contemporary Methods of Remineralization
NCT number | NCT03780270 |
Other study ID # | 500 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 16, 2014 |
Est. completion date | December 31, 2016 |
Verified date | December 2018 |
Source | University Dentistry Clinical Center of Kosovo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 90 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 15 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Dentistry Clinical Center of Kosovo |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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