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

Phase 3

Recruiting

• Conditions: White Spot Lesion of Tooth
• Interventions: Drug: Self-assembling peptide (P11-4); Drug: CPP-ACFP; Other: Control Group, No Treatment; Drug: Resin infiltration

• Registration Number: NCT05206539
• Lead Sponsor: Plovdiv Medical University

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-09
• Study Start: 2024-06-01
• Primary Completion: 2025-03
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SAP11-4 group (Gr CR)	Self-assembling peptide (P11-4)	The Gr CR will receive treatment with Curodont RepairTM (Credentis; Windisch, Switzerland), according to the manufacturer's instructions.
CPP-ACFP group (Gr V)	CPP-ACFP	The Gr V will receive treatment with MI varnishTM (GC Corporation, Tokyo, Japan), according to the manufacturer's instructions.
Control group (Gr NT)	Control Group, No Treatment	The control group (Gr NT) receive no intervention except brushing twice daily with aminofluoride toothpaste and toothbrush provided by researcher.
Resin infiltration group (Gr I)	Resin infiltration	The Gr I receive treatment with Icon Vestibular (DMG, Germany), according to the manufacturer's instructions.

Primary Outcome Measures

Name	Time	Method
Change in lesion fluorescence evaluated using diode laser fluorescence device.	12 months: (Baseline, 1 month, 3 months, 6months and 12 months)	Laser fluorescence values are categorized: 20-24; * Category 0= LF values 0-7, caries-free enamel surface; * Category 1=LF values 8-14, caries extending up to halfway through the enamel; * Category 2=LF values 15-24, caries in the inner half of enamel; * Category 3= LF values \>24, caries in dentine

Secondary Outcome Measures

Name	Time	Method
Visual assessment using ICDAS II coding system	12 months: (Baseline, 1 month, 3 months, 6months and 12 months)	Code 0 Sound tooth surface: Code 1: First visual change in enamel. Code 2: Distinct visual change in enamel visible when wet, lesion must be visible when dry.; Code 3: Localized enamel breakdown because of caries with no visible dentin or underlying shadow.; Code 4: Underlying dark shadow from dentin with or without localized enamel breakdown.; Code 5: Distinct cavity with visible dentin. Code 6: Extensive distinct cavity with visible dentin. After treatment, the evaluation will be performed as follows. If the score has increased to ICDAS 3 or more indicates caries progression and if it decreases to 0-1 this indicates caries regression; if score remains the same this indicates no change in lesion. No. of lesions with scores 0,1,2,3 or more will be assessed and analyzed.
Activity of a carious lesion using Nyvad Caries Diagnostic Criteria	12 months: (Baseline, 1 month, 3 months, 6months and 12 months)	Code 0: Sound - Normal enamel Code 1: Active caries (intact surface) - Surface of enamel is whitish/yellowish opaque Code 2: Active caries (surface discontinuity) Code 3: Active caries (cavity) - Enamel/dentin cavity easily visible with the naked eye.; Code 4: Inactive caries (intact surface) - Surface of enamel is whitish, brownish or black.; Code 5: Inactive caries (surface discontinuity) - Same criteria as score 4. Localized surface defect (microcavity) in enamel only Code 6: Inactive caries (cavity) - Enamel/dentin cavity easily visible with the naked eye; surface of cavity may be shiny and feels hard on probing with gentle pressure.; Code 7: Filling (sound surface) Code 8: Filling + active caries - Caries lesion may be cavitated or noncavitated.; Code 9: Filling + inactive caries - Caries lesion may be cavitated or noncavitated.

Trial Locations

Locations (1)

Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv; 🇧🇬 Plovdiv, Bulgaria