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Effect of Low-viscosity Resin Infiltration on Color Change of Enamel White Spot Lesions

Efficacy of the Application of the Low-viscosity Resin Infiltration on the Change of Color of the Enamel White Spot Lesions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05757440
Enrollment
49
Registered
2023-03-07
Start date
2020-11-20
Completion date
2023-01-30
Last updated
2023-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion of Tooth

Keywords

Low-viscosity resin infiltration, Icon, color change, white spot enamel lesions

Brief summary

this study aimed to assess the effect of the application of the low-viscosity Icon resin infiltrate on the color change of the diagnosed white spot enamel lesions (WSLs) over 3-, 6-, and 12-m follow-up periods. The ICDAS scoring system was used to visually diagnose WSLs in a total of 96 anterior teeth in 49 participants and the teeth were then were evaluated for their color change using a spectrophotometer. According to the manufacturer directions the Icon kit was applied to the WSLs-diagnosed teeth as follows: the WSLs were treated with 15% hydrofluoric acid (Icon-Etch) was applied to the lesions for 120 seconds then it was rinsed for 30 seconds. Next, the etched WSLs were treated with 99% ethanol (Icon-dry) and for 30 seconds. Then the Icon-Resin was applied and light cured for 40 seconds. The change of color was done after 3-, 6- and 12-month . The mean and standard deviation values were statistically analyzed with the repeated measure ANOVA test and the Paired sample t-test.

Detailed description

The early caries may not be noticeable till it appears as rough enamel surface that might has chalky-white or even dark spots of brown color with no cavities formed. These spots reported were referred to as the white spot enamel lesions, that can be visually diagnosed with the ICDAS scoring method (International Caries Detection and Assessment System) that was proposed for the assessment of caries including early enamel lesions that are not yet cavitated and appear after through dryness of the enamel surface. Remineralization of the white spots enamel lesion presents the first choice treatment option. Still it has some short-outcomes, such as the staining-ability and unreliable esthetic results. It was reported that the Icon resin infiltration to masking the white spot enamel lesion at the minute of its application without a detectable change of color up to a period of six months. The Icon resin infiltration technique depends on its low-viscosity that enables its penetration into enamel surface through capillary action, occluding the micro porosities created in the enamel as a result of the white enamel lesions development. So that, the progression of the lesion would be stopped. Therefore, this clinical study was conducted to assess the effectiveness of the application of the Icon resin infiltration on the change of the color change of the white spot enamel lesions at follow-up periods of 3-, 6-, and 12-months.

Interventions

OTHERIcon resin application

Application of the low-viscosity resin infiltration (Icon) to the white spot enamel lesions

Sponsors

National Research Centre, Egypt
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Age range 14-18 years, * Good general health, * Permanent dentition, * Sound anterior teeth, * Non-cavitated white spot enamel lesions.

Exclusion criteria

* Presence of current orthodontic treatments, * Presence of retained teeth, * Presence of congenital or developmental anomalies in the permanent dentition, * Students having systematic conditions, * Smoking, * Bad oral hygiene, * General health problems, * Missed anterior teeth, * Carious anterior teeth, * Intrinsic and extrinsic staining * Presence of anterior restorations.

Design outcomes

Primary

MeasureTime frameDescription
Color changeImmediate after the application of the Icon resinUsing the intraoral spectrophotometer, which measures the color differences at the specific follow-up periods. The color difference (ΔE) was calculated with the equation: ΔE\*Lab= \[(ΔL 2) + (Δa 2) + (Δb 2)\] ½. Where L\* value represents the lightness of an object, The degree of redness and greenness is represented by a\* values, while the degree of blue and yellow components of color was determined by b\* values. A higher Delta E means more significant color shift.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026