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

NCT06566833 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: 00010556 - IORG 0008839
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

White Spot Lesion

Keywords

curodont repair fluoride plus; CPP-ACPF; sodium fluoride varnish; guided enamel regeneration

Outcome Measures

Primary Outcomes (1)

• Assessing the remineralization of early carious lesions in primary teeth

  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

  3,6,9 and12 months

Secondary Outcomes (2)

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

  12 months

• comparing the antibacterial effect of different remineralizing agents against streptococcus mutans

  3 months

Study Arms (3)

curodont repair fluoride plus

EXPERIMENTAL

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

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

CPP-ACPF varnish

EXPERIMENTAL

casein phoshphopeptide amorphous calcium phosphate fluoride (CPP-ACPF )

Drug: Casein phosphopeptide amorphous calcium phosphate

5 % sodium fluoride varnish

ACTIVE COMPARATOR

5% sodium fluoride varnish

Drug: 5% sodium fluoride varnish

Interventions

self assmbling peptide p11-4 combined with 0.05% fluoride DRUG

biomimetic remineralizing agent

Also known as: SAP P11-4

curodont repair fluoride plus

Casein phosphopeptide amorphous calcium phosphate DRUG

remineralizing agents that acts as a fluoride booster

Also known as: CPP-ACPF

CPP-ACPF varnish

5% sodium fluoride varnish DRUG

remineralizing agent that is used as a gold standard for remineralization

Also known as: 5% NaF

5 % sodium fluoride varnish

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Karin Dowidar

Alexandria, Professor, Egypt

Location

Related Publications (1)

• Mekky AI, Dowidar KML, Talaat DM. Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish in Remineralization of Early Carious Lesions in Primary Dentition: Randomized Clinical Trial. Pediatr Dent. 2021 Jan 15;43(1):17-23.

  PMID: 33662244 BACKGROUND

MeSH Terms

Interventions

Fluorides; casein phosphopeptide-amorphous calcium phosphate nanocomplex

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Study Officials

• karin dowidar, professor

  faculty of Dentistry, Alexandria university, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 22, 2024
• Study Start: August 15, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)