Dental FluorosisNCT07704983
Resin Infiltration Versus Microabrasion With CPP-ACP for Fluorotic White Spot Lesions
A study testing Resin infiltration and Enamel Microabrasion Plus CPP-ACP in people with Dental Fluorosis, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Dental fluorosis can cause visible chalky-white spots on the front teeth. These white spot lesions may affect dental appearance even when the tooth surface is intact. This randomized clinical trial compared two minimally invasive approaches for masking fluorotic white spot lesions on permanent anterior teeth. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Fluorosis
- What is being tested?
- Resin infiltration and Enamel Microabrasion Plus CPP-ACP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2023to 30 Jun 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients presenting with fluorotic white spot lesions on permanent anterior teeth.
- Shallow fluorotic white spot lesions confined to the outer enamel.
- Chalky-white lesions with a clear border from adjacent sound enamel.
- Lesions appearing bright on oblique visual inspection and mildly dim under diagnostic transillumination.
- Clinical diagnosis of dental fluorosis based on the characteristic bilateral, symmetrical, and diffuse distribution of enamel opacities.
- Willingness to participate in the study and comply with treatment and follow-up visits.
Who cannot join
- Deep subsurface enamel lesions.
- Lesions consistent with molar-incisor hypomineralization.
- Lesions with yellow or brown discoloration.
- Known allergy or hypersensitivity to ICON, Opalustre, Tooth Mousse, or their components.
- Inability to tolerate rubber-dam isolation.
- Poor oral hygiene.
- Inability or unwillingness to attend the scheduled follow-up assessments.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
Huế, 530000
About this study
Official title: Resin Infiltration Versus Microabrasion Combined With CPP-ACP for Masking Fluorotic Anterior White Spot Lesions: A 6-Month Randomized Controlled Clinical Trial
Dental fluorosis can cause visible chalky-white spots on the front teeth. These white spot lesions may affect dental appearance even when the tooth surface is intact.
This randomized clinical trial compared two minimally invasive approaches for masking fluorotic white spot lesions on permanent anterior teeth. Eligible teeth were randomly assigned to receive either resin infiltration or enamel microabrasion followed by application of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP).
The main outcomes were the color difference between the white spot lesion and the surrounding sound enamel and the proportion of the visible tooth surface occupied by the lesion. These outcomes were evaluated from standardized clinical photographs before treatment, after treatment, and during follow-up through 6 months.
Read the detailed description
This was a prospective, controlled, two-arm randomized clinical trial conducted at the Dental Clinic of the University of Medicine and Pharmacy Hospital, Hue University, Vietnam, between June 2023 and June 2025. Patients with fluorotic white spot lesions on permanent anterior teeth were enrolled. Eligible lesions were shallow, chalky-white enamel opacities confined to the outer enamel and clinically consistent with dental fluorosis.
Randomization was performed at the tooth level. A total of 60 eligible teeth were allocated in a 1:1 ratio to one of two treatment groups: resin infiltration or enamel microabrasion followed by CPP-ACP application. Allocation was concealed using sequentially numbered, opaque, sealed envelopes. All procedures were performed by one operator under standardized clinical conditions.
In the resin-infiltration group, the lesion surface was treated with 15% hydrochloric acid, rinsed and dried, followed by ethanol application. A low-viscosity resin infiltrant was then applied and light-cured according to the study protocol.
In the microabrasion plus CPP-ACP group, the labial enamel surface was treated with a hydrochloric-acid and silicon-carbide microabrasion material using repeated polishing cycles. CPP-ACP paste was then applied to the treated surface for 5 minutes.
Two co-primary outcomes were evaluated from standardized clinical photographs: the color difference between the lesion and adjacent sound enamel, expressed as ΔE in the CIELab* color space, and the lesion-area ratio, expressed as the percentage of the visible labial tooth surface occupied by the lesion. Images were obtained under reproducible lighting, magnification, camera-positioning, and patient-positioning conditions.
Color measurements were obtained from sampled points within the lesion and adjacent sound enamel. Lesion area and total labial-surface area were outlined and measured using image-analysis software. Outcome assessments were performed by an independent examiner who was blinded to treatment allocation using coded image files. Measurements were obtained before treatment and at prespecified post-treatment and follow-up assessments through 6 months.
- Conditions
- Dental Fluorosis
- Being tested
- Resin infiltration, Enamel Microabrasion Plus CPP-ACP
- Keywords
- Fluorotic White Spot Lesions, Resin Infiltration, CPP-ACP, Anterior Teeth, Minimally Invasive Dentistry
- Medical subject headings
- Fluorosis, Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationProcedure or surgery
After tooth cleaning and rubber-dam isolation, 15% hydrochloric acid was applied to the fluorotic white spot lesion for 120 seconds, rinsed for 30 seconds, and air-dried. Ethanol was applied for 30 seconds to assess lesion masking, and the etching step was repeated if the lesion remained visible. A low-viscosity resin infiltrant was applied for 180 seconds, excess material was removed, and the surface was light-cured for 40 seconds. A second application was performed for 60 seconds and light-cured for an additional 40 seconds.
Enamel Microabrasion Plus CPP-ACPProcedure or surgery
After tooth cleaning and rubber-dam isolation, an enamel microabrasion material containing 6.6% hydrochloric acid and silicon carbide particles was applied to the labial enamel surface and polished with a rubber cup at approximately 500 rpm for 60 seconds. The surface was rinsed, and the procedure was repeated for five cycles. CPP-ACP paste was then applied to the treated enamel surface for 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Resin Infiltration | Experimental | Eligible fluorotic white spot lesions were treated with resin infiltration using the ICON Vestibular Kit. After rubber-dam isolation, 15% hydrochloric acid was applied for 120 seconds, rinsed for 30 seconds, and air-dried. Ethanol was applied for 30 seconds, and the etching step was repeated if needed. The resin infiltrant was then applied, excess material was removed, and the surface was light-cured according to the study protocol. Receives: Procedure: Resin infiltration |
| Microabrasion Plus CPP-ACP | Active comparator | Eligible fluorotic white spot lesions were treated with enamel microabrasion followed by CPP-ACP application. Opalustre containing 6.6% hydrochloric acid and silicon carbide particles was applied to the labial enamel surface and polished with a rubber cup at approximately 500 rpm for 60 seconds. The procedure was repeated for five cycles, followed by application of CPP-ACP gel for 5 minutes. Receives: Procedure: Enamel Microabrasion Plus CPP-ACP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIELAB Color Difference Between the Fluorotic Lesion and Adjacent Sound Enamel
The color difference between the fluorotic white spot lesion and adjacent sound enamel was measured from standardized clinical photographs in the CIELab* color space. Mean L*, a*, and b* values were obtained from three points within the lesion and three points on adjacent sound enamel located 2 mm from the lesion margin. Color difference was calculated as ΔE = [(ΔL*)² + (Δa*)² + (Δb*)²]¹ᐟ². Lower ΔE values indicate better color matching and lesion masking. A ΔE value below 3.7 was considered not clinically perceptible to the naked eye.
Measured: At baseline and four post-treatment assessments through 6 months (T0-T4)
Fluorotic Lesion-Area Ratio on the Labial Tooth Surface
The fluorotic white spot lesion and the visible labial tooth surface were outlined on standardized clinical photographs and measured using ImageJ. The lesion-area ratio was calculated as R (%) = (lesion area / total visible labial surface area) × 100. Scores range from 0% to 100%, with lower values indicating a smaller visible lesion area and better lesion masking.
Measured: At baseline and four post-treatment assessments through 6 months (T0-T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jun 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental FluorosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hue University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Van Nhat Thang, Hue University of Medicine and Pharmacy
- Investigators
- Van Nhat Thang Le, DDS PhD, Principal investigator, Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704983
- Sponsor's protocol ID
- H2023/124
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resin Infiltration Versus Microabrasion Combined With CPP-ACP for Masking Fluorotic Anterior White Spot Lesions: A 6-Month Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07704983
- Acronym / sponsor ID
- H2023/124
- Conditions
- Dental Fluorosis
- Keywords
- Fluorotic White Spot Lesions, Resin Infiltration, CPP-ACP, Anterior Teeth, Minimally Invasive Dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hue University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 15 Jul 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.
Dental fluorosis can cause visible chalky-white spots on the front teeth. These white spot lesions may affect dental appearance even when the tooth surface is intact.
This randomized clinical trial compared two minimally invasive approaches for masking fluorotic white spot lesions on permanent anterior teeth. Eligible teeth were randomly assigned to receive either resin infiltration or enamel microabrasion followed by application of casein phosphopeptide-amorphous calcium phosphate (CPP-ACP).
The main outcomes were the color difference between the white spot lesion and the surrounding sound enamel and the proportion of the visible tooth surface occupied by the lesion. These outcomes were evaluated from standardized clinical photographs before treatment, after treatment, and during follow-up through 6 months.
Detailed description
This was a prospective, controlled, two-arm randomized clinical trial conducted at the Dental Clinic of the University of Medicine and Pharmacy Hospital, Hue University, Vietnam, between June 2023 and June 2025. Patients with fluorotic white spot lesions on permanent anterior teeth were enrolled. Eligible lesions were shallow, chalky-white enamel opacities confined to the outer enamel and clinically consistent with dental fluorosis.
Randomization was performed at the tooth level. A total of 60 eligible teeth were allocated in a 1:1 ratio to one of two treatment groups: resin infiltration or enamel microabrasion followed by CPP-ACP application. Allocation was concealed using sequentially numbered, opaque, sealed envelopes. All procedures were performed by one operator under standardized clinical conditions.
In the resin-infiltration group, the lesion surface was treated with 15% hydrochloric acid, rinsed and dried, followed by ethanol application. A low-viscosity resin infiltrant was then applied and light-cured according to the study protocol.
In the microabrasion plus CPP-ACP group, the labial enamel surface was treated with a hydrochloric-acid and silicon-carbide microabrasion material using repeated polishing cycles. CPP-ACP paste was then applied to the treated surface for 5 minutes.
Two co-primary outcomes were evaluated from standardized clinical photographs: the color difference between the lesion and adjacent sound enamel, expressed as ΔE in the CIELab* color space, and the lesion-area ratio, expressed as the percentage of the visible labial tooth surface occupied by the lesion. Images were obtained under reproducible lighting, magnification, camera-positioning, and patient-positioning conditions.
Color measurements were obtained from sampled points within the lesion and adjacent sound enamel. Lesion area and total labial-surface area were outlined and measured using image-analysis software. Outcome assessments were performed by an independent examiner who was blinded to treatment allocation using coded image files. Measurements were obtained before treatment and at prespecified post-treatment and follow-up assessments through 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resin Infiltration | Experimental | Procedure: Resin infiltrationEligible fluorotic white spot lesions were treated with resin infiltration using the ICON Vestibular Kit. After rubber-dam isolation, 15% hydrochloric acid was applied for 120 seconds, rinsed for 30 seconds, and air-dried. Ethanol was applied for 30 seconds, and the etching step was repeated if needed. The resin infiltrant was then applied, excess material was removed, and the surface was light-cured according to the study protocol. |
| Microabrasion Plus CPP-ACP | Active comparator | Procedure: Enamel Microabrasion Plus CPP-ACPEligible fluorotic white spot lesions were treated with enamel microabrasion followed by CPP-ACP application. Opalustre containing 6.6% hydrochloric acid and silicon carbide particles was applied to the labial enamel surface and polished with a rubber cup at approximately 500 rpm for 60 seconds. The procedure was repeated for five cycles, followed by application of CPP-ACP gel for 5 minutes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients presenting with fluorotic white spot lesions on permanent anterior teeth.
- Shallow fluorotic white spot lesions confined to the outer enamel.
- Chalky-white lesions with a clear border from adjacent sound enamel.
- Lesions appearing bright on oblique visual inspection and mildly dim under diagnostic transillumination.
- Clinical diagnosis of dental fluorosis based on the characteristic bilateral, symmetrical, and diffuse distribution of enamel opacities.
Key exclusion criteria (7 listed)
- Deep subsurface enamel lesions.
- Lesions consistent with molar-incisor hypomineralization.
- Lesions with yellow or brown discoloration.
- Known allergy or hypersensitivity to ICON, Opalustre, Tooth Mousse, or their components.
- Inability to tolerate rubber-dam isolation.
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 |
|---|---|---|
| Resin infiltrationAfter tooth cleaning and rubber-dam isolation, 15% hydrochloric acid was applied to the fluorotic white spot lesion for 120 seconds, rinsed for 30 seconds, and air-dried. Ethanol was applied for 30 seconds to assess lesion masking, and the etching step was repeated if the lesion remained visible. A low-viscosity resin infiltrant was applied for 180 seconds, excess material was removed, and the surface was light-cured for 40 seconds. A second application was performed for 60 seconds and light-cured for an additional 40 seconds. | Procedure or surgery | Resin Infiltration |
| Enamel Microabrasion Plus CPP-ACPAfter tooth cleaning and rubber-dam isolation, an enamel microabrasion material containing 6.6% hydrochloric acid and silicon carbide particles was applied to the labial enamel surface and polished with a rubber cup at approximately 500 rpm for 60 seconds. The surface was rinsed, and the procedure was repeated for five cycles. CPP-ACP paste was then applied to the treated enamel surface for 5 minutes. | Procedure or surgery | Microabrasion Plus CPP-ACP |
Primary outcome
CIELAB Color Difference Between the Fluorotic Lesion and Adjacent Sound Enamel
Time frame: At baseline and four post-treatment assessments through 6 months (T0-T4)
The color difference between the fluorotic white spot lesion and adjacent sound enamel was measured from standardized clinical photographs in the CIELab* color space. Mean L*, a*, and b* values were obtained from three points within the lesion and three points on adjacent sound enamel located 2 mm from the lesion margin. Color difference was calculated as ΔE = [(ΔL*)² + (Δa*)² + (Δb*)²]¹ᐟ². Lower ΔE values indicate better color matching and lesion masking. A ΔE value below 3.7 was considered not clinically perceptible to the naked eye.
Fluorotic Lesion-Area Ratio on the Labial Tooth Surface
Time frame: At baseline and four post-treatment assessments through 6 months (T0-T4)
The fluorotic white spot lesion and the visible labial tooth surface were outlined on standardized clinical photographs and measured using ImageJ. The lesion-area ratio was calculated as R (%) = (lesion area / total visible labial surface area) × 100. Scores range from 0% to 100%, with lower values indicating a smaller visible lesion area and better lesion masking.
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 15 Jul 2026.
- 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.
Van Nhat Thang Le, DDS PhD principal investigator
Faculty of Odonto-Stomatology, University of Medicine and Pharmacy, Hue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin infiltration and Enamel Microabrasion Plus CPP-ACP in people with Dental Fluorosis, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
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 6 inclusion and 7 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 15 Jul 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 Vietnam. 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?
CIELAB Color Difference Between the Fluorotic Lesion and Adjacent Sound Enamel (time frame: At baseline and four post-treatment assessments through 6 months (T0-T4)). The study lists 2 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 15 Jul 2026.