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Completed

NCT Number: NCT06821724

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

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

Completed

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Key information

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre

Dokki, Giza Governorate, 12622, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Unwillingness to be randomly assigned to 1 of the 3 treatment groups.
  • Presence of abnormal oral, medical, or mental condition.
  • Presence of any milk-related allergies.
  • Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
  • Presence of periodontal pockets around maxillary anterior teeth.

Treatment and study plan

Casein phosphopeptide-amorphous calcium phosphate

Drug

Intervention

Other names: (CPP-ACP) (MI paste)

Casein phosphopeptide-amorphous calcium phosphate + fluoride

Drug

Intervention

Other names: (CPP-ACP) + (MI paste plus)

Nano hydroxyapatite paste

Drug

Intervention

Other names: (Apagard primo toothpaste)

Fluoride gel

Drug

Positive control

Other names: Active Comparator

Primary outcomes

  1. Assessment of color change

    Time frame: 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 outcomes

  1. Remineralization assessment

    Time frame: 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)".

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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