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

Alexandria University

Status and phase: Completed; Early Phase 1

Conditions: White Spot Lesion

Treatments: Drug: Casein phosphopeptide amorphous calcium phosphate; Drug: 5% sodium fluoride varnish; Drug: self assmbling peptide p11-4 combined with 0.05% fluoride

Study type: Interventional

Funder types: Other

Identifiers

NCT06566833

00010556 - IORG 0008839

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

curodont repair fluoride plus

Experimental group

Description:

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

Treatment:

Drug: self assmbling peptide p11-4 combined with 0.05% fluoride

CPP-ACPF varnish

Experimental group

Description:

casein phoshphopeptide amorphous calcium phosphate fluoride (CPP-ACPF )

Treatment:

Drug: Casein phosphopeptide amorphous calcium phosphate

5 % sodium fluoride varnish

Active Comparator group

Description:

5% sodium fluoride varnish

Treatment:

Drug: 5% sodium fluoride varnish