NCT06566833

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 3 Years – 6 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• White Spot Lesion

Interventions

Type	Name	Description
DRUG	self assmbling peptide p11-4 combined with 0.05% fluoride	biomimetic remineralizing agent
DRUG	Casein phosphopeptide amorphous calcium phosphate	remineralizing agents that acts as a fluoride booster
DRUG	5% sodium fluoride varnish	remineralizing agent that is used as a gold standard for remineralization

Timeline

• Start date: 2023-08-15
• Primary completion: 2024-10-15
• Completion: 2024-10-15
• First posted: 2024-08-22
• Last updated: 2025-01-29

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study