Trials / Completed
CompletedNCT03865680
Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth
Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth (Randomized Clinical Trial)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- Nourhan M.Aly · Academic / Other
- Sex
- All
- Age
- 3 Years – 5 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to evaluate the effectiveness of Casein phosphopeptide-amorphous calcium phosphate fluoride varnish (CPP-ACP FV) in comparison to fluoride varnish (FV) as a remineralizing agent for white spot lesions in primary teeth (WSLs).
Detailed description
The study is a two parallel arms double blinded randomized controlled clinical trial. A total of 180 WSL in primary teeth in chikdren aged 2-5 y and satisfying the inclusion criteria were selected. Patients will be randomly allocated into 2 groups allocated to two varnishes: study group: CPP-ACP FV (MI varnish), Control group FV (Duraphat). Both fluoride varnishes applications are applied with identical intensive protocols every 2 weeks for 6 weeks. The application of each varnish will be according to manufacturer's instructions. The operator is not blinded to treatment type. Only the participants and statistician are blinded to treatment groups. The whole sample (N=180) will be followed up at 6 weeks and at 18 and 30 weeks for Visio-tactile assessment and DIAGNOdent measurements
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CPP-ACP | The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions. |
| DRUG | Duraphat | The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions. |
Timeline
- Start date
- 2019-04-28
- Primary completion
- 2020-03-25
- Completion
- 2020-04-10
- First posted
- 2019-03-07
- Last updated
- 2020-04-22
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT03865680. Inclusion in this directory is not an endorsement.