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)

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.

Study Overview

• Status: Completed
• Conditions: White Spot Lesion
• Intervention / Treatment: Drug: self assmbling peptide p11-4 combined with 0.05% fluoride; Drug: Casein phosphopeptide amorphous calcium phosphate; Drug: 5% sodium fluoride varnish

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Professor
    • Alexandria, Professor, Egypt
      • Karin Dowidar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: curodont repair fluoride plus; self-assembling peptide (p11-4) with 0.05% sodium fluoride	Drug: self assmbling peptide p11-4 combined with 0.05% fluoride; biomimetic remineralizing agent; Other Names: SAP P11-4
Experimental: CPP-ACPF varnish; casein phoshphopeptide amorphous calcium phosphate fluoride (CPP-ACPF )	Drug: Casein phosphopeptide amorphous calcium phosphate; remineralizing agents that acts as a fluoride booster; Other Names: CPP-ACPF
Active Comparator: 5 % sodium fluoride varnish; 5% sodium fluoride varnish	Drug: 5% sodium fluoride varnish; remineralizing agent that is used as a gold standard for remineralization; Other Names: 5% NaF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparing the change in esthetic appearance of early carious lesion before and after treatment	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	12 months
comparing the antibacterial effect of different remineralizing agents against streptococcus mutans	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	3 months

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Study Director: karin dowidar, professor, Faculty of Dentistry, Alexandria University, Egypt

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Actual): October 15, 2024
• Study Completion (Actual): October 15, 2024

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: sodium fluoride varnish; CPP-ACPF; curodont repair fluoride plus; guided enamel regeneration
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries; Calcium-Regulating Hormones and Agents; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Chelating Agents; Sequestering Agents; Anti-Infective Agents, Local; Cariostatic Agents; Calcium; Fluorides; Listerine; Sodium Fluoride; Caseins; Fluorides, Topical
• Other Study ID Numbers: 00010556 - IORG 0008839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only the results of the primary and secondary outcomes of the study will be published after study completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes