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

Plovdiv Medical University

Status and phase: Enrolling; Phase 3

Conditions: White Spot Lesion of Tooth

Treatments: Other: Control Group, No Treatment; Drug: CPP-ACFP; Drug: Self-assembling peptide (P11-4); Drug: Resin infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT05206539

MU_WSL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 9 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants in the study are children 9 to 17 years old.
• Obtained written informed consent from parents or gave-givers as well as obtained verbal informed consent from the child to participate in the study, in which procedures are explained in age-appropriate manner.
• Children, identified as positive or definitely positive through Frankl behavioral rating scale.
• Presence of at least four initial carious lesions of smooth surface (white spots) in permanent teeth that reach the inside of the enamel but are not cavitated, estimated with ICDAS system values 01 (first visible enamel change) and 02 (localized visible enamel change), Nyvad caries activity criteria (1 -active, noncavited lesion) and DIAGNOdent pen values up to 24.
• Study participants did not conduct remineralizing or topical fluorine therapy of the lesions involved up to six months prior to inclusion in the study.
• Children without a history of allergy to the administered medications

Exclusion criteria

• Patients with general diseases or conditions associated with decreased salivation and intake of medications suppressing salivary current. Children with cognitive and behavioral disorders. The presence of a disease is confirmed by an anamnestic interview with the parent.
• Children with a history of allergy to the administered medications
• Patient with non-carious lesion such as enamel hypoplasia, or any developmental defects.
• Patient received restorations or any remineralizing agent other than the regular toothpaste during the last 6 months.
• Participant in another trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 4 patient groups, including a placebo group

SAP11-4 group (Gr CR)

Experimental group

Description:

The Gr CR will receive treatment with Curodont RepairTM (Credentis; Windisch, Switzerland), according to the manufacturer's instructions.

Treatment:

Drug: Self-assembling peptide (P11-4)

CPP-ACFP group (Gr V)

Active Comparator group

Description:

The Gr V will receive treatment with MI varnishTM (GC Corporation, Tokyo, Japan), according to the manufacturer's instructions.

Treatment:

Drug: CPP-ACFP

Resin infiltration group (Gr I)

Active Comparator group

Description:

The Gr I receive treatment with Icon Vestibular (DMG, Germany), according to the manufacturer's instructions.

Treatment:

Drug: Resin infiltration

Control group (Gr NT)

Placebo Comparator group

Description:

The control group (Gr NT) receive no intervention except brushing twice daily with aminofluoride toothpaste and toothbrush provided by researcher.

Treatment:

Other: Control Group, No Treatment