Clinical trial NCT05206539: Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children
Official title: Efficacy of Self-assembling Peptide P11-4, Casein Phosphopeptide - Amorphous Calcium Fluoride Phosphate and Resin Infiltrant in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: White Spot Lesion of Tooth
Keywords: white spot lesions
initial caries
early caries lesions
self-assembling peptide p11-4
cpp-acfp
resin infiltrant
icon infiltration
non-operative dental treatment
Lead sponsor: Plovdiv Medical University
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The trial to be conducted is a randomized controlled clinical crossover experimental study with split-mouth design. The within-subject design randomly allocates experimental and control interventions to different areas in the oral cavity (teeth, surfaces, arches, quadrants) and has the advantage of reducing outcome variability estimation since each patient is its own control, leading to potential increase in statistical power.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in lesion fluorescence evaluated using diode laser fluorescence device.
timeFrame: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
Secondary outcomes:
measure: Visual assessment using ICDAS II coding system
timeFrame: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
measure: Activity of a carious lesion using Nyvad Caries Diagnostic Criteria
timeFrame: 12 months: (Baseline, 1 month, 3 months, 6months and 12 months)
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv
Study officials:
affiliation: Medical University Plovdiv, Bulgaria
name: Ani Belcheva, PhD
role: STUDY_DIRECTOR
References: