Effect of Different Remineralizing Agents on White Spot Lesions Treatment in Children
NCT ID: NCT06821724
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2024-12-01
2025-02-01
Brief Summary
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Detailed Description
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Group one: No treatment was applied (negative control). Group two: Fluoride gel was applied for 5 minutes (positive control). Group three: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste) was applied for 5 minutes.
Group four: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus) were applied for 5 minutes.
Group five: Nano hydroxyapatite paste (Apagard primo toothpaste) was be applied for 5 minutes.
All children involved in this study were instructed to brush their teeth under the supervision of the researcher before the application of the studied agent.
Each agent was applied to the labial surfaces of each tooth affected with white spot lesion for 5 minutes after cleaning and drying with a cotton roll using an applicator tip. After each application, children were instructed not to eat or drink for one hour. This application was be repeated in-office after one then after two weeks then after six weeks.
Participants received a sterilized pouch containing a sterile container with one of the pastes according to the study group for home application. The application of the paste was carried out under parental supervision and was asked to apply each of the pastes at home three times a day till the end of the study
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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No treatment
Negative control
No interventions assigned to this group
Fluoride gel
Positive control
Fluoride gel
Positive control
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste)
Intervention
Casein phosphopeptide-amorphous calcium phosphate
Intervention
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus)
Intervention
Casein phosphopeptide-amorphous calcium phosphate + fluoride
Intervention
Nano hydroxyapatite paste (Apagard primo toothpaste)
Intervention
Nano hydroxyapatite paste
Intervention
Interventions
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Casein phosphopeptide-amorphous calcium phosphate
Intervention
Casein phosphopeptide-amorphous calcium phosphate + fluoride
Intervention
Nano hydroxyapatite paste
Intervention
Fluoride gel
Positive control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Good oral hygiene and regular tooth brushing at least twice daily.
Exclusion Criteria
2. Presence of abnormal oral, medical, or mental condition.
3. Presence of any milk-related allergies.
4. Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
5. Presence of periodontal pockets around maxillary anterior teeth.
10 Years
14 Years
ALL
Yes
Sponsors
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National Research Centre, Egypt
OTHER
Responsible Party
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Mohamed Farouk Rashed
Researcher of Pediatric Dentistry
Principal Investigators
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Mohamed F Rashed, Researcher
Role: STUDY_DIRECTOR
National Research Centre, Egypt
Locations
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National Research Centre
Dokki, Giza Governorate, Egypt
Countries
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References
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El Mansy MM, Rashed MF, Saleh RS. Effect of remineralization after in office followed by home treatment of white spot lesions in children randomized controlled trial. Sci Rep. 2025 Aug 19;15(1):30448. doi: 10.1038/s41598-025-15829-5.
Other Identifiers
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342
Identifier Type: -
Identifier Source: org_study_id
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