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

NCT ID: NCT06821724

Last Updated: 2025-02-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-02-01

Brief Summary

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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

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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

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White Spot Lesion of Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Randomized controlled parallel double blinded study
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Blinding to the child participants and legal guardian of each participating child, inter examiner and statistician. The operator and the child were blinded to the intervention from the beginning till teeth polishing. Blinding cannot be done during application of remineralizing agents because of clear visual differences between these agents.

Study Groups

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No treatment

Negative control

Group Type NO_INTERVENTION

No interventions assigned to this group

Fluoride gel

Positive control

Group Type ACTIVE_COMPARATOR

Fluoride gel

Intervention Type DRUG

Positive control

Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste)

Intervention

Group Type EXPERIMENTAL

Casein phosphopeptide-amorphous calcium phosphate

Intervention Type DRUG

Intervention

Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus)

Intervention

Group Type EXPERIMENTAL

Casein phosphopeptide-amorphous calcium phosphate + fluoride

Intervention Type DRUG

Intervention

Nano hydroxyapatite paste (Apagard primo toothpaste)

Intervention

Group Type EXPERIMENTAL

Nano hydroxyapatite paste

Intervention Type DRUG

Intervention

Interventions

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Casein phosphopeptide-amorphous calcium phosphate

Intervention

Intervention Type DRUG

Casein phosphopeptide-amorphous calcium phosphate + fluoride

Intervention

Intervention Type DRUG

Nano hydroxyapatite paste

Intervention

Intervention Type DRUG

Fluoride gel

Positive control

Intervention Type DRUG

Other Intervention Names

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(CPP-ACP) (MI paste) (CPP-ACP) + (MI paste plus) (Apagard primo toothpaste) Active Comparator

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Farouk Rashed

Researcher of Pediatric Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Egypt

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.

Reference Type DERIVED
PMID: 40830200 (View on PubMed)

Other Identifiers

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342

Identifier Type: -

Identifier Source: org_study_id

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