Caries Clinical Trial
— infiltrationOfficial title:
Randomized Clinical Trial on Resin Infiltration Versus Fluoride Varnish Treatment of Early Smooth-surface Caries Lesions in Deciduous Teeth
Verified date | June 2013 |
Source | Medical University of Warsaw |
Contact | n/a |
Is FDA regulated | No |
Health authority | Poland: Ethics Committee |
Study type | Interventional |
It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth reduce considerably the progression of treated caries lesions, compared to fluoride varnish therapy only.
Status | Completed |
Enrollment | 81 |
Est. completion date | August 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Months to 71 Months |
Eligibility |
Inclusion Criteria: - at least two active smooth-surface caries lesions in deciduous teeth (ICDAS II code 2) - a written consent of parents/ guardians for participation in the research study Exclusion Criteria: - age above 5.9 years - systematic disease - cavitated lesions - enamel defects - current participation in another study - a planned change of residence within one year |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Poland | Dorota Olczak-Kowalczyk | Warsaw | Warsaw, 18 Miodowa St |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only. | The condition of treated white spot lesions (WSL) were scored using the Nyvad et al. system (17): I-WSL (Inactive WSL) - inactive spot lesion, when surface was becoming smooth, hard and glossy; S -WSL (Sound WSL) - invisible spot lesion taking the appearance of healthy enamel with proper translucency level and surface texture. Active enamel lesions and assessment scores 3-6 according to ICDAS II within a year were considered as decayed (D-Enamel/Dental cavity). Treatment was considered successful when lesions did not progress (I-WSL or S-WSL); unsuccessful when lesions remained active and enamel underwent erosion - i.e. caries occurred (D). | one year | Yes |
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