Resin Infiltration Versus Microabrasion With CPP-ACP for Fluorotic White Spot Lesions

NCT07704983 | Completed

• 1 other identifier: H2023/124
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Dental fluorosis can cause visible chalky-white spots on the front teeth. These white spot lesions may affect dental appearance even when the tooth surface is intact. This randomized clinical trial compared two minimally invasive approaches for masking fluorotic white spot lesions on permanent anterior teeth. Eligible teeth were randomly assigned to receive either resin infiltration or enamel microabrasion followed by application of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP). The main outcomes were the color difference between the white spot lesion and the surrounding sound enamel and the proportion of the visible tooth surface occupied by the lesion. These outcomes were evaluated from standardized clinical photographs before treatment, after treatment, and during follow-up through 6 months.

Conditions

Dental Fluorosis

Keywords

Fluorotic White Spot Lesions; Resin Infiltration; CPP-ACP; Anterior Teeth; Minimally Invasive Dentistry

Outcome Measures

Primary Outcomes (2)

• CIELAB Color Difference Between the Fluorotic Lesion and Adjacent Sound Enamel

  The color difference between the fluorotic white spot lesion and adjacent sound enamel was measured from standardized clinical photographs in the CIELab\* color space. Mean L\*, a\*, and b\* values were obtained from three points within the lesion and three points on adjacent sound enamel located 2 mm from the lesion margin. Color difference was calculated as ΔE = \[(ΔL\*)² + (Δa\*)² + (Δb\*)²\]¹ᐟ². Lower ΔE values indicate better color matching and lesion masking. A ΔE value below 3.7 was considered not clinically perceptible to the naked eye.

  At baseline and four post-treatment assessments through 6 months (T0-T4)

• Fluorotic Lesion-Area Ratio on the Labial Tooth Surface

  The fluorotic white spot lesion and the visible labial tooth surface were outlined on standardized clinical photographs and measured using ImageJ. The lesion-area ratio was calculated as R (%) = (lesion area / total visible labial surface area) × 100. Scores range from 0% to 100%, with lower values indicating a smaller visible lesion area and better lesion masking.

  At baseline and four post-treatment assessments through 6 months (T0-T4)

Study Arms (2)

Resin Infiltration

EXPERIMENTAL

Eligible fluorotic white spot lesions were treated with resin infiltration using the ICON Vestibular Kit. After rubber-dam isolation, 15% hydrochloric acid was applied for 120 seconds, rinsed for 30 seconds, and air-dried. Ethanol was applied for 30 seconds, and the etching step was repeated if needed. The resin infiltrant was then applied, excess material was removed, and the surface was light-cured according to the study protocol.

Procedure: Resin infiltration

Microabrasion Plus CPP-ACP

ACTIVE COMPARATOR

Eligible fluorotic white spot lesions were treated with enamel microabrasion followed by CPP-ACP application. Opalustre containing 6.6% hydrochloric acid and silicon carbide particles was applied to the labial enamel surface and polished with a rubber cup at approximately 500 rpm for 60 seconds. The procedure was repeated for five cycles, followed by application of CPP-ACP gel for 5 minutes.

Procedure: Enamel Microabrasion Plus CPP-ACP

Interventions

Resin infiltration PROCEDURE

After tooth cleaning and rubber-dam isolation, 15% hydrochloric acid was applied to the fluorotic white spot lesion for 120 seconds, rinsed for 30 seconds, and air-dried. Ethanol was applied for 30 seconds to assess lesion masking, and the etching step was repeated if the lesion remained visible. A low-viscosity resin infiltrant was applied for 180 seconds, excess material was removed, and the surface was light-cured for 40 seconds. A second application was performed for 60 seconds and light-cured for an additional 40 seconds.

Resin Infiltration

Enamel Microabrasion Plus CPP-ACP PROCEDURE

After tooth cleaning and rubber-dam isolation, an enamel microabrasion material containing 6.6% hydrochloric acid and silicon carbide particles was applied to the labial enamel surface and polished with a rubber cup at approximately 500 rpm for 60 seconds. The surface was rinsed, and the procedure was repeated for five cycles. CPP-ACP paste was then applied to the treated enamel surface for 5 minutes.

Microabrasion Plus CPP-ACP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting with fluorotic white spot lesions on permanent anterior teeth.
• Shallow fluorotic white spot lesions confined to the outer enamel.
• Chalky-white lesions with a clear border from adjacent sound enamel.
• Lesions appearing bright on oblique visual inspection and mildly dim under diagnostic transillumination.
• Clinical diagnosis of dental fluorosis based on the characteristic bilateral, symmetrical, and diffuse distribution of enamel opacities.
• Willingness to participate in the study and comply with treatment and follow-up visits.

You may not qualify if:

• Deep subsurface enamel lesions.
• Lesions consistent with molar-incisor hypomineralization.
• Lesions with yellow or brown discoloration.
• Known allergy or hypersensitivity to ICON, Opalustre, Tooth Mousse, or their components.
• Inability to tolerate rubber-dam isolation.
• Poor oral hygiene.
• Inability or unwillingness to attend the scheduled follow-up assessments.

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: lead

Study Sites (1)

Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University

Huế, 530000, Vietnam

Location

MeSH Terms

Conditions

Fluorosis, Dental

Interventions

Enamel Microabrasion; casein phosphopeptide-amorphous calcium phosphate nanocomplex

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Esthetics, Dental; Dentistry

Study Officials

• Van Nhat Thang Le, DDS PhD

  Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: June 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)