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

Not Applicable

Completed

• Conditions: White Spot Lesion of Tooth
• Interventions: Drug: Fluoride gel; Drug: Casein phosphopeptide-amorphous calcium phosphate; Drug: Casein phosphopeptide-amorphous calcium phosphate + fluoride; Drug: Nano hydroxyapatite paste

• Registration Number: NCT06821724
• Lead Sponsor: National Research Centre, Egypt

Brief 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

Study Timeline

• Study Start: 2024-12-01
• Primary Completion: 2025-01-15
• Status Verified: 2025-02
• Study Completion: 2025-02-01
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Presence of at least one tooth affected by white spot lesion.
2. Good oral hygiene and regular tooth brushing at least twice daily.

Exclusion Criteria

1. Unwillingness to be randomly assigned to 1 of the 3 treatment groups.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Fluoride gel	Fluoride gel	Positive control
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste)	Casein phosphopeptide-amorphous calcium phosphate	Intervention
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus)	Casein phosphopeptide-amorphous calcium phosphate + fluoride	Intervention
Nano hydroxyapatite paste (Apagard primo toothpaste)	Nano hydroxyapatite paste	Intervention

Primary Outcome Measures

Name	Time	Method
Assessment of color change	before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment	Color change assessmentof white spot lesions using "Easy-shade" device

Secondary Outcome Measures

Name	Time	Method
Remineralization assessment	before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment	Remineralization assessment will be done using Laser fluorescence device "DIAGNOdent® (KaVo)".

Trial Locations

Locations (1)

National Research Centre; 🇪🇬 Dokki, Giza, Egypt