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

February 6, 2025 updated by: Mohamed Farouk Rashed, National Research Centre, Egypt

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Giza
      • Dokki, Giza, Egypt, 12622
        • National Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No treatment
Negative control
Active Comparator: Fluoride gel
Positive control
Drug: Fluoride gel
Positive control
Other Names:
  • Active Comparator
Experimental: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste)
Intervention
Drug: Casein phosphopeptide-amorphous calcium phosphate
Intervention
Other Names:
  • (CPP-ACP) (MI paste)
Experimental: Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus)
Intervention
Drug: Casein phosphopeptide-amorphous calcium phosphate + fluoride
Intervention
Other Names:
  • (CPP-ACP) + (MI paste plus)
Experimental: Nano hydroxyapatite paste (Apagard primo toothpaste)
Intervention
Drug: Nano hydroxyapatite paste
Intervention
Other Names:
  • (Apagard primo toothpaste)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)".
before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Centre, Egypt

Investigators

  • Study Director: Mohamed F Rashed, Researcher, National Research Centre, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Actual)

January 15, 2025

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 342

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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