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

NCT05206539 | Recruiting Phase 3

• 1 other identifier: MU_WSL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in lesion fluorescence evaluated using diode laser fluorescence device.

  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

  12 months: (Baseline, 1 month, 3 months, 6months and 12 months)

Secondary Outcomes (2)

• Visual assessment using ICDAS II coding system

  12 months: (Baseline, 1 month, 3 months, 6months and 12 months)

• Activity of a carious lesion using Nyvad Caries Diagnostic Criteria

  12 months: (Baseline, 1 month, 3 months, 6months and 12 months)

Study Arms (4)

SAP11-4 group (Gr CR)

EXPERIMENTAL

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

Drug: Self-assembling peptide (P11-4)

CPP-ACFP group (Gr V)

ACTIVE COMPARATOR

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

Drug: CPP-ACFP

Resin infiltration group (Gr I)

ACTIVE COMPARATOR

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

Drug: Resin infiltration

Control group (Gr NT)

PLACEBO COMPARATOR

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

Other: Control Group, No Treatment

Interventions

Self-assembling peptide (P11-4) DRUG

Prior to application, teeth are isolated by cotton rolls and gently air dried. The surface of the lesion is conditioned with a 2% sodium hypochlorite solution for 20 s and then rinse with water. Application of 35% phosphoric acid etching gel for 20 sec followed by rinsing with water-air spray for 30 sec. Drying the surface with compressed oil-free air for 60 sec. Curodont Repair is dissolve in 0.05 ml of distilled water and applied to the surface and allowed to work for about 5 min. Participants will receive oral hygiene instructions.

Also known as: Curodont Repair

SAP11-4 group (Gr CR)

CPP-ACFP DRUG

Prior to application, teeth are isolated by cotton rolls and gently air dried. Application of fluoride varnish with a brush applicator on the surface of the teeth for 5 minutes. Patients is advising not to brush their teeth or chew food for at least 4 h after treatment. Participants will receive oral hygiene instructions

Also known as: MI varnishTM (GC Corporation, Tokyo, Japan), RecaldentTM (CPP-ACP)

CPP-ACFP group (Gr V)

Resin infiltration DRUG

The validated ICON Vestibular (DMG) infiltration lesion infiltration protocol is applied. Icon Etch (DMG) etching gel containing 15% hydrochloric acid is applied for 120 seconds using an applicator. It is then removed by rinsing thoroughly with water-air spray for 30 seconds. Then follows application of pure alcohol - Icon Dry (DMG) for 30 seconds for complete drying of the lesion and additional drying compressed oil-free air for 40 sec. Application of Icon Infiltrant (DMG) using a microapplicator allows it to penetrate for 3 minutes, during which, if necessary, it is reapplied several times. Excess material is removed with dry microbrushes and followed by light curing for 40 seconds. Re-applying of the infiltrate for 1 minute, removal of excess material, light curing for 40 seconds. Participants will receive oral hygiene instructions

Also known as: Icon Vestibular (DMG; Hamburg, Germany)

Resin infiltration group (Gr I)

Control Group, No Treatment OTHER

Everyday oral hygiene instructions Subjects will receive non-prescription fluoride toothpaste (1400 ppm Fluoride, Elmex junior) and oral hygiene instructions. The dosage will be 1/2 inch strip of paste 2x/day for 8 weeks. Subjects will apply paste to a toothbrush and brush teeth thoroughly for at least 1 minute then expectorate and rinse.

Also known as: Home Oral Care

Control group (Gr NT)

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Children without a history of allergy to the administered medications

You may not qualify if:

• 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.

Sponsors & Collaborators

• Plovdiv Medical University: lead

Study Sites (1)

Department of Pediatric Dentistry, Faculty of Dental Medicine, Medical University - Plovdiv

Plovdiv, 4000, Bulgaria

RECRUITING

MeSH Terms

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplex; Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ani Belcheva, PhD

  Medical University Plovdiv, Bulgaria

  STUDY DIRECTOR

Central Study Contacts

Irina Uzunova, DMD

CONTACT

+359899984312; iuzunova.raycheva@gmail.com

Elitsa Veneva, DMD, PhD

CONTACT

+359898424151; elitza.veneva@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: This is a double-blinded trial, i.e., where patients and outcomes assessor are not aware which white spot lesion what treatment will receive, unlike the operator which is not blinded for the study due to the nature of the investigated techniques.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 25, 2022
• Study Start: June 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)