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

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

EARLY_PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2024-10-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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White Spot Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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curodont repair fluoride plus

self-assembling peptide (p11-4) with 0.05% sodium fluoride

Group Type EXPERIMENTAL

self assmbling peptide p11-4 combined with 0.05% fluoride

Intervention Type DRUG

biomimetic remineralizing agent

CPP-ACPF varnish

casein phoshphopeptide amorphous calcium phosphate fluoride (CPP-ACPF )

Group Type EXPERIMENTAL

Casein phosphopeptide amorphous calcium phosphate

Intervention Type DRUG

remineralizing agents that acts as a fluoride booster

5 % sodium fluoride varnish

5% sodium fluoride varnish

Group Type ACTIVE_COMPARATOR

5% sodium fluoride varnish

Intervention Type DRUG

remineralizing agent that is used as a gold standard for remineralization

Interventions

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self assmbling peptide p11-4 combined with 0.05% fluoride

biomimetic remineralizing agent

Intervention Type DRUG

Casein phosphopeptide amorphous calcium phosphate

remineralizing agents that acts as a fluoride booster

Intervention Type DRUG

5% sodium fluoride varnish

remineralizing agent that is used as a gold standard for remineralization

Intervention Type DRUG

Other Intervention Names

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SAP P11-4 CPP-ACPF 5% NaF

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes