White Spot Lesion of ToothNCT07799350
Clinical Outcomes, Cost-Effectiveness and Patient Satisfaction of Two Resin Infiltration Systems for The Management of White Spot Lesions
A study testing light cured low viscosity resin infiltration in people with White Spot Lesion of Tooth, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to clinically evaluate and compare the color matching of white spot lesions (WSLs) following treatment with two resin infiltration systems: ICON resin infiltration and I-Mate resin infiltration. Read more about this study
- Who is it for?
- Ages 16 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- light cured low viscosity resin infiltration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2026to 22 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients presenting with non-cavitated white spot lesions on anterior permanent teeth.
- White spot lesions associated with previous orthodontic treatment. Lesions with intact surface enamel and no cavitation. Patients aged 16 to 35 years. Patients with good oral hygiene. Patients willing to participate in the study. Patients able to attend the scheduled follow-up visits. Patients who provide informed consent.
Who cannot join
- Cavitated carious lesions. Spontaneous or elicited pain associated with the affected tooth. Tooth mobility. Signs or symptoms of pulpal or periapical pathology. Severe periodontal or oral conditions that may interfere with treatment or assessment.
- Developmental enamel defects or other conditions that may interfere with assessment of white spot lesions.
- Known allergy or sensitivity to any component of the materials used in the study.
- Teeth with previous esthetic restorations or other treatments that may affect color assessment.
- Patients unable to attend the scheduled follow-up visits. Poor oral hygiene that may interfere with treatment or assessment. Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to clinically evaluate and compare the color matching of white spot lesions (WSLs) following treatment with two resin infiltration systems: ICON resin infiltration and I-Mate resin infiltration. The study will assess the ability of both materials to improve the esthetic appearance of white spot lesions and achieve a color match with the surrounding natural tooth structure.
Read the detailed description
White spot lesions (WSLs) are a common esthetic complication associated with orthodontic treatment and are characterized by subsurface enamel demineralization with preservation of the superficial enamel layer. These lesions may remain visible after orthodontic appliance removal and can negatively affect the patient's dental esthetics and satisfaction.
Resin infiltration is a minimally invasive treatment approach that aims to arrest the progression of early enamel caries and improve the optical appearance of WSLs. The infiltration of a low-viscosity resin into the porous enamel lesion modifies the refractive properties of the lesion and may reduce the visual contrast between the white spot lesion and the surrounding sound enamel.
This randomized controlled clinical trial will compare two resin infiltration systems, ICON and I-Mate, in the management of white spot lesions. Participants with eligible white spot lesions will be randomly allocated to receive treatment with either ICON resin infiltration or I-Mate resin infiltration according to the manufacturers' recommended clinical protocols.
The primary outcome of the study will be the clinical color matching of the treated white spot lesions with the adjacent natural tooth structure. Color matching will be evaluated using standardized clinical assessment criteria to determine the esthetic improvement achieved following resin infiltration treatment.
- Conditions
- White Spot Lesion of Tooth
- Being tested
- light cured low viscosity resin infiltration
- Keywords
- resin infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light cured low viscosity resin infiltrationBehavioural
light cured low viscosity resin infiltration used to mask white spot lesion appearance
| Study group | Role | What they receive |
|---|---|---|
| ICON resin infiltration | Active comparator | ICON resin infiltration is a minimally invasive treatment for non-cavitated white spot lesions. The lesion surface will be prepared according to the manufacturer's recommended clinical protocol, followed by application of ICON-Dry and ICON-Infiltrant to allow resin penetration into the porous enamel lesion. The resin will then be light-cured according to the manufacturer's instructions, followed by finishing and polishing. Receives: Behavioral: light cured low viscosity resin infiltration |
| IMATE resin infiltration | Experimental | I-Mate resin infiltration will be applied for the management of non-cavitated white spot lesions according to the manufacturer's recommended clinical protocol. The lesion will be appropriately prepared to facilitate resin penetration, followed by application and light-curing of the infiltrant according to the manufacturer's instructions. Finishing and polishing will be performed after resin infiltration. Receives: Behavioral: light cured low viscosity resin infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
color matching of the treated white spot lesion with the adjacent natural tooth structure
Color match of treated teeth will be assessed using the FDI World Dental Federation Esthetic Criteria. The color match will be evaluated using the FDI 5-point ordinal scale, and the mean color match score will be calculated for each treatment group.
Measurement: Color match score Measurement tool: FDI World Dental Federation Esthetic Criteria Unit: FDI color match score
Measured: baseline , 3months , 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start29 Aug 2026 (estimated)
- Primary completion29 Aug 2027 (estimated)
- Study completion22 Sep 2027 (estimated)
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ali Mohammed Yassin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799350
- Sponsor's protocol ID
- 14422025471541
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes, Cost-Effectiveness and Patient Satisfaction of Two Resin Infiltration Systems for The Management of White Spot Lesions
- ClinicalTrials.gov ID
- NCT07799350
- Acronym / sponsor ID
- 14422025471541
- Conditions
- White Spot Lesion of Tooth
- Keywords
- resin infiltration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Aug 2026 (estimated)
- Primary completion
- 29 Aug 2027 (estimated)
- Study completion
- 22 Sep 2027 (estimated)
- First posted
- 2 Sep 2026 (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.
The aim of this study is to clinically evaluate and compare the color matching of white spot lesions (WSLs) following treatment with two resin infiltration systems: ICON resin infiltration and I-Mate resin infiltration. The study will assess the ability of both materials to improve the esthetic appearance of white spot lesions and achieve a color match with the surrounding natural tooth structure.
Detailed description
White spot lesions (WSLs) are a common esthetic complication associated with orthodontic treatment and are characterized by subsurface enamel demineralization with preservation of the superficial enamel layer. These lesions may remain visible after orthodontic appliance removal and can negatively affect the patient's dental esthetics and satisfaction.
Resin infiltration is a minimally invasive treatment approach that aims to arrest the progression of early enamel caries and improve the optical appearance of WSLs. The infiltration of a low-viscosity resin into the porous enamel lesion modifies the refractive properties of the lesion and may reduce the visual contrast between the white spot lesion and the surrounding sound enamel.
This randomized controlled clinical trial will compare two resin infiltration systems, ICON and I-Mate, in the management of white spot lesions. Participants with eligible white spot lesions will be randomly allocated to receive treatment with either ICON resin infiltration or I-Mate resin infiltration according to the manufacturers' recommended clinical protocols.
The primary outcome of the study will be the clinical color matching of the treated white spot lesions with the adjacent natural tooth structure. Color matching will be evaluated using standardized clinical assessment criteria to determine the esthetic improvement achieved following resin infiltration treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICON resin infiltration | Active comparator | Behavioral: light cured low viscosity resin infiltrationICON resin infiltration is a minimally invasive treatment for non-cavitated white spot lesions. The lesion surface will be prepared according to the manufacturer's recommended clinical protocol, followed by application of ICON-Dry and ICON-Infiltrant to allow resin penetration into the porous enamel lesion. The resin will then be light-cured according to the manufacturer's instructions, followed by finishing and polishing. |
| IMATE resin infiltration | Experimental | Behavioral: light cured low viscosity resin infiltrationI-Mate resin infiltration will be applied for the management of non-cavitated white spot lesions according to the manufacturer's recommended clinical protocol. The lesion will be appropriately prepared to facilitate resin penetration, followed by application and light-curing of the infiltrant according to the manufacturer's instructions. Finishing and polishing will be performed after resin infiltration. |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients presenting with non-cavitated white spot lesions on anterior permanent teeth.
- White spot lesions associated with previous orthodontic treatment. Lesions with intact surface enamel and no cavitation. Patients aged 16 to 35 years. Patients with good oral hygiene. Patients willing to participate in the study. Patients able to attend the scheduled follow-up visits. Patients who provide informed consent.
Key exclusion criteria (5 listed)
- Cavitated carious lesions. Spontaneous or elicited pain associated with the affected tooth. Tooth mobility. Signs or symptoms of pulpal or periapical pathology. Severe periodontal or oral conditions that may interfere with treatment or assessment.
- Developmental enamel defects or other conditions that may interfere with assessment of white spot lesions.
- Known allergy or sensitivity to any component of the materials used in the study.
- Teeth with previous esthetic restorations or other treatments that may affect color assessment.
- Patients unable to attend the scheduled follow-up visits. Poor oral hygiene that may interfere with treatment or assessment. Refusal to participate in the study.
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 |
|---|---|---|
| light cured low viscosity resin infiltrationlight cured low viscosity resin infiltration used to mask white spot lesion appearance | Behavioural | ICON resin infiltration, IMATE resin infiltration |
Primary outcome
color matching of the treated white spot lesion with the adjacent natural tooth structure
Time frame: baseline , 3months , 6 months and 12 months
Color match of treated teeth will be assessed using the FDI World Dental Federation Esthetic Criteria. The color match will be evaluated using the FDI 5-point ordinal scale, and the mean color match score will be calculated for each treatment group. Measurement: Color match score Measurement tool: FDI World Dental Federation Esthetic Criteria Unit: FDI color match score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing light cured low viscosity resin infiltration in people with White Spot Lesion of Tooth, run by Cairo University 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact manar khaled, bachelor degree (BDS) (01060631025, Manar_said@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
color matching of the treated white spot lesion with the adjacent natural tooth structure (time frame: baseline , 3months , 6 months and 12 months). 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 2 Sep 2026.