CompletedNot Applicable

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

Egypt49 participantsStarted 2020-11-20

Plain-language 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.

Who can participate

Age range

14 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Color change

Timeframe: Immediate after the application of the Icon resin

Color change

Timeframe: At 3 months

Color change

Timeframe: At 6 months

Color change

Timeframe: At 12 months

Trial details

NCT IDNCT05757440

SponsorNational Research Centre, Egypt

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-30

View on ClinicalTrials.gov More White Spot Lesion of Tooth trials

Plain-language summary

Who can participate

Age range

14 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.