Efficacy of Different Agents in Treatment of Initial Caries on Smooth

Status Recruiting

Clinical Trial Summary

White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries. Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients using visual assessments and laser fluorescence investigation.

Clinical Trial Description

White spot lesions (WSL) are characterized by an apparently intact outer surface and a demineralized subsurface, and are considered the first clinical sign of dental caries. These lesions are characterized by white chalky appearance. As caries is reversible under favorable conditions, many approaches have focused on treating it as soon as possible1. Aim of this study is to determine the treatment potential of self-assembling peptide (P11-4), casein phosphopeptide-amorphos calcium fluoride phosphate (CPP-ACFP) and resin infiltration technique to reverse or arrest the WSLs in the same oral environments in pediatric patients. This will be achieved using visual assessments and laser fluorescence investigation. The proposed study is a randomized controlled clinical trial with split-mouth design. Included are forty positive patients aged 9-17 years, with at least four visible WSL on smooth surfaces in permanent teeth, requiring non-operative treatment. WSL will be assessed visually by ICDAS II, Nyvad criteria and laser fluorescence (LF pen). The lesions are randomly assigned into 4 groups (n = 40): Gr NT (no treatment, control group), Gr CR (Curodont Repair), Gr V (MI Varnish), Gr I (Icon) groups. Lesions will be assessed by International Caries Detection and Assessment System, Nyvad caries activity criteria and laser fluorescence at baseline and follow-up period after1, 3, 6 and 12 months. Data will be analyzed with intention-to-treat concept by Student T-test for paired samples, Wilcoxon signed rank test, P< .05. Pre-test on 20 subjects resulted in n=41 patients sample size. ;

Study Design

Related Conditions & MeSH terms

White Spot Lesion of Tooth

Clinical Trial Details

NCT number	NCT05206539
Study type	Interventional
Source	Plovdiv Medical University
Contact	Irina Uzunova, DMD
Phone	+359899984312
Email	iuzunova.raycheva@gmail.com
Status	Recruiting
Phase	Phase 3
Start date	June 1, 2024
Completion date	April 2025

View Details

See also
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Terminated	`NCT04827966` - Remineralization Agents for the Treatment of White Spot Lesions	N/A
Not yet recruiting	`NCT03973554` - Caries Prevention Potential of Pearl Powder Versus CPP-ACP on Enamel White Spot Lesions	Phase 2
Completed	`NCT05757440` - Effect of Low-viscosity Resin Infiltration on Color Change of Enamel White Spot Lesions	N/A
Completed	`NCT05871619` - Combined Application of Diode Laser and Different Remineralizing Agents on White Spot Lesions	N/A
Not yet recruiting	`NCT03930927` - Effect of Self Assembling Peptide on White Spot Lesion	Early Phase 1
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Completed	`NCT03526276` - Effect of Different Pastes on Remineralization of Early Caries Lesions in Primary Teeth	N/A
Recruiting	`NCT03823612` - Reminerlization Potential of Innovative Biomimetic Material in Caries White Spot Lesions	Phase 4
Completed	`NCT04401280` - Bioactive Glass in the Treatment of Enamel White Spot Lesions	Phase 3
Completed	`NCT03738839` - A Comparative Assessment of Orthodontic Treatment Outcomes Using the Quantitative Light-Induced Fluorescence Method	N/A
Recruiting	`NCT04994314` - White Spot Lesions Prevention During Orthodontic Fixed Appliance Treatment: a Randomized Clinical Trial	Phase 3
Completed	`NCT04992481` - Fluoride Varnish, Ozone, Octenidin and WSLs in Orthodontic Patients	N/A
Active, not recruiting	`NCT05764187` - Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets	N/A
Recruiting	`NCT03217084` - Treatment of Postorthodontic White Spot Lesions	Phase 4
Recruiting	`NCT06402500` - Color Masking Potential of Bioactive and ICON Materials	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms