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Completed

NCT Number: NCT06566833

Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth

the primary aim of the study is remineralization of early carious lesions in primary teeth using different remineralizing agents of different remineralizing strategies when applied in an intensive mode. The secondary aim of the study is to compare their antibacterial effect against streptococcus mutans and their effect on reducing the size of the lesions.

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Key information

Conditions

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Karin Dowidar

Alexandria, Professor, Egypt

About this study

The primary aim of the study is to compare the effect of curodont repair fluoride plus (self-assembling peptide p11-4 with 0.5% sodium fluoride) with MI varnish (casein phosphopeptide amorphous calcium phosphate fluoride) and Colgate fluoride varnish (5% sodium fluoride) in remineralization of early carious lesions in primary anterior teeth. The study sample is consisted of 66 patients aged 3-6 years old with at least 2 white spot lesions in their primary anterior teeth who are assigned into control group (n=22): colgate fluoride varnish, test group 1(n=22): MI varnish and test group 2 (n=22) :curodont repair fluoride plus. Each material is applied once every 2 weeks for 3 times (intensive mode of application). The secondary aim of the study is to determine the antibacterial effect of each material against streptococcus mutans is compared by obtaining a plaque sample at baseline then after application by 48 hours, 1 months and 3 months and culturing using disk diffusion method for determining the log count of streptococcus mutans at each time point. Another secondary aim is to determine the change in lesion size at baseline and after 6 months and 12 months using standardized photographs with a digital camera.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy children
  • age range 3-6
  • at least 2 early carious lesions

Exclusion criteria

  • Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases.
  • Application of fluoride varnish less than 3 months prior to study treatment.
  • Any metabolic disorders affecting bone turnover.
  • Concurrent participation in another clinical trial.
  • Patients receiving any antibiotic within 1 month prior to plaque sample collection

Treatment and study plan

self assmbling peptide p11-4 combined with 0.05% fluoride

Drug

biomimetic remineralizing agent

Other names: SAP P11-4

Casein phosphopeptide amorphous calcium phosphate

Drug

remineralizing agents that acts as a fluoride booster

Other names: CPP-ACPF

5% sodium fluoride varnish

Drug

remineralizing agent that is used as a gold standard for remineralization

Other names: 5% NaF

Primary outcomes

  1. Assessing the remineralization of early carious lesions in primary teeth

    Time frame: 3,6,9 and12 months

    comparing the remineralization effect of different remineralizing agents both qualitatively by comparing the change in ICDAS -11 criteria and quantitatively by using laser fluorescence scores using kavo DIAGNOdent classic after intensive mode of application of the different remineralizing agents

Secondary outcomes

  1. comparing the change in esthetic appearance of early carious lesion before and after treatment

    Time frame: 12 months

    comparing the change in lesion size using standardized photographs quantitatively by calculating pixel size of the lesion before treatment and after 6 and 12 months of intensive mode of application of the different remineralizing agents using ImageJ software program for image analysis. Assessing the esthetic appearance of the lesions will be done subjectively by using a visual analogue scale score from 1 to 7

  2. comparing the antibacterial effect of different remineralizing agents against streptococcus mutans

    Time frame: 3 months

    Supragingival plaque samples will be collected at baseline then after 48 hours, 1 months and 3 months of application of the materials in an intensive mode. log count of streptococcus mutans is determined using disk diffusion method using mitis salivaris agar plates

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effectiveness of Different Remineralizing Strategies on the Management of Early Carious Lesions in Primary Teeth (Randomized Controlled Clinical Trial)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Jan 29, 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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