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

Primary Purpose

White Spot Lesion of Tooth

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Icon resin application
Sponsored by
National Research Centre, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for White Spot Lesion of Tooth focused on measuring Low-viscosity resin infiltration, Icon, color change, white spot enamel lesions

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Research Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icon resin

Arm Description

Low-viscosity Icon resin infiltration

Outcomes

Primary Outcome Measures

Color change
Using 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.
Color change
Using 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.
Color change
Using 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.
Color change
Using 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.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
March 3, 2023
Sponsor
National Research Centre, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05757440
Brief Title
Effect of Low-viscosity Resin Infiltration on Color Change of Enamel White Spot Lesions
Official Title
Efficacy of the Application of the Low-viscosity Resin Infiltration on the Change of Color of the Enamel White Spot Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Research Centre, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
White Spot Lesion of Tooth
Keywords
Low-viscosity resin infiltration, Icon, color change, white spot enamel lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Icon resin
Arm Type
Experimental
Arm Description
Low-viscosity Icon resin infiltration
Intervention Type
Other
Intervention Name(s)
Icon resin application
Intervention Description
Application of the low-viscosity resin infiltration (Icon) to the white spot enamel lesions
Primary Outcome Measure Information:
Title
Color change
Description
Using 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.
Time Frame
Immediate after the application of the Icon resin
Title
Color change
Description
Using 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.
Time Frame
At 3 months
Title
Color change
Description
Using 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.
Time Frame
At 6 months
Title
Color change
Description
Using 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.
Time Frame
At 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lamiaa M Moharam, Assoc Prof.
Organizational Affiliation
National Research Centre, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
National Research Centre
City
Cairo
State/Province
Giza
ZIP/Postal Code
12622
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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