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

NCT05757440 | Completed DMC

• 1 other identifier: 20157
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesion of Tooth

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  Immediate after the application of the Icon resin

• 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.

  At 3 months

• 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.

  At 6 months

• 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.

  At 12 months

Study Arms (1)

Icon resin

EXPERIMENTAL

Low-viscosity Icon resin infiltration

Other: Icon resin application

Interventions

Icon resin application OTHER

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

Icon resin

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Centre, Egypt: lead

Study Sites (1)

National Research Centre

Cairo, Giza Governorate, 12622, Egypt

Location

Study Officials

• Lamiaa M Moharam, Assoc Prof.

  National Research Centre, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: March 7, 2023
• Study Start: November 20, 2020
• Primary Completion: November 30, 2022
• Study Completion: January 30, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)