NCT06821724

Effect of Different Remineralizing Agents on White Spot Lesions Treatment in Children

Comparative Study on the Effect of Different Remineralizing Agents Versus Fluoride Gel on White Spot Lesions After In-Office Followed by Home Treatment in Children: A Randomized Controlled Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: National Research Centre, Egypt · Academic / Other
• Sex: All
• Age: 10 Years – 14 Years
• Healthy volunteers: Accepted

Summary

One hundred children with white spot lesions on their teeth were divivided into 5 groups of different remineralizing agents to assess their effect on color change and remineralization

Detailed description

Children having at least one tooth clinically diagnosed by white spot lesion were randomly allocated to five groups. 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

• White Spot Lesion of Tooth

Interventions

Type	Name	Description
DRUG	Casein phosphopeptide-amorphous calcium phosphate	Intervention
DRUG	Casein phosphopeptide-amorphous calcium phosphate + fluoride	Intervention
DRUG	Nano hydroxyapatite paste	Intervention
DRUG	Fluoride gel	Positive control

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-01-15
• Completion: 2025-02-01
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: Egypt