White Spot Lesion of ToothNCT05757440
Effect of Low-viscosity Resin Infiltration on Color Change of Enamel White Spot Lesions
A study testing Icon resin application in people with White Spot Lesion of Tooth, run by National Research Centre, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- Icon resin application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2020to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age range 14-18 years,
- Good general health,
- Permanent dentition,
- Sound anterior teeth,
- Non-cavitated white spot enamel lesions.
Who cannot join
- 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,
Show all 11Show fewer
- General health problems,
- Missed anterior teeth,
- Carious anterior teeth,
- Intrinsic and extrinsic staining
- Presence of anterior restorations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Application of the Low-viscosity Resin Infiltration on the Change of Color of the Enamel White Spot Lesions
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.
Read the 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.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- Icon resin application
- Keywords
- Low-viscosity resin infiltration, Icon, color change, white spot enamel lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icon resin applicationOther
Application of the low-viscosity resin infiltration (Icon) to the white spot enamel lesions
| Study group | Role | What they receive |
|---|---|---|
| Icon resin | Experimental | Low-viscosity Icon resin infiltration Receives: Other: Icon resin application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start20 Nov 2020
- Primary completion30 Nov 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot Lesion of ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lamiaa M Moharam, Assoc Prof., Study director, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757440
- Sponsor's protocol ID
- 20157
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Application of the Low-viscosity Resin Infiltration on the Change of Color of the Enamel White Spot Lesions
- ClinicalTrials.gov ID
- NCT05757440
- Acronym / sponsor ID
- 20157
- Conditions
- White Spot Lesion of Tooth
- Keywords
- Low-viscosity resin infiltration, Icon, color change, white spot enamel lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icon resin | Experimental | Other: Icon resin applicationLow-viscosity Icon resin infiltration |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age range 14-18 years,
- Good general health,
- Permanent dentition,
- Sound anterior teeth,
- Non-cavitated white spot enamel lesions.
Key exclusion criteria (11 listed)
- Presence of current orthodontic treatments,
- Presence of retained teeth,
- Presence of congenital or developmental anomalies in the permanent dentition,
- Students having systematic conditions,
- Smoking,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Icon resin applicationApplication of the low-viscosity resin infiltration (Icon) to the white spot enamel lesions | Other | Icon resin |
Primary outcome
Color change
Time frame: Immediate after the application of the Icon resin
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
Time frame: At 3 months
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
Time frame: At 6 months
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
Time frame: At 12 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lamiaa M Moharam, Assoc Prof. study director
National Research Centre, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Icon resin application in people with White Spot Lesion of Tooth, run by National Research Centre, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color change (time frame: Immediate after the application of the Icon resin). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.