White Spot LesionsNCT07426432
Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy
A study testing Application of fluoride-releasing composite and Application of conventional composite in people with White Spot Lesions and Clear Aligner Appliance, run by Mansoura University at 1 site in Egypt.
Trial summary
Aim of this study: evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions. Material and methods: Type: Prospective, randomized split mouth controlled study. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesions, Clear Aligner Appliance
- What is being tested?
- Application of fluoride-releasing composite and Application of conventional composite
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Sep 2026
- 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 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients aged 16-24 years.
- Good general and oral health.
- Mild dental crowding per arch (≤ 4 mm).
Who cannot join
- Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
- Patients with Cleft lip and palate.
- Previous orthodontic treatment.
- Dental fluorosis.
- Hypocalcified teeth or visible demineralization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy: A Controlled Split-Mouth Study
Aim of this study: evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions.
Material and methods:
Type: Prospective, randomized split mouth controlled study.
Interventions:
Intervention Group (Experimental Side):
•Application of fluoride-releasing composite
Control Group (Control Side):
•Application of conventional composite
Outcome Measures:
Primary Outcome: Incidence and Severity of White Spot Lesions
Secondary Outcomes:
- Periodontal Ligament (PDL) Health
- Gingival Bleeding and Inflammation
Read the detailed description
Aim of the Study:
The aim of this study is to evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions (WSLs) development during clear aligner therapy in comparison to a split-mouth controlled group.
Material and methods:
Study Design:
Each participant will have one side of the mouth assigned to fluoride-releasing composite intervention as attachments, while the contralateral side will be assigned to conventional composite as attachments.
Sample size calculation:
Sample size calculation was based on effect of fluoride-releasing composite resin on prevention of White Spot Lesions during Clear Aligner Therapy: that was retrieved from most similar research Abdullah et al. Using G power program version 3.1.9.7 to calculate sample size based on effect size of 1.08 that is based on mean area of white spots, using 2-tailed test, α error = 0.05 and power = 95% , the total calculated sample size will be 24 in each group. To mitigate the potential impact of an anticipated 20% dropout rate, the recruitment target was increased to 30 patients per treatment group, aiming to ensure adequate statistical power in the final analyzed sample.
Inclusion Criteria:
- Patients aged 16-24 years.
- Good general and oral health.
- Mild dental crowding per arch (≤ 4 mm).
Exclusion Criteria:
- Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
- Patients with Cleft lip and palate.
- Previous orthodontic treatment.
- Dental fluorosis.
- Hypocalcified teeth or visible demineralization.
Interventions:
- Initial Oral Scan: A 3D oral scan of the arch to be treated will be performed using a digital intraoral scanner
- Aligner Fabrication: Aligners will be fabricated using thermoforming techniques. Intervention Group (Experimental Side): application of a fluoride-releasing composite on the indicated side of the mouth as attachments. Control Group (Control Side): application of conventional composite as attachments.
- Aligner Placement: the aligners will be fitted, and patients will wear them continuously, except during eating and brushing.
Outcome Measures:
Primary Outcome: Incidence and Severity of White Spot Lesions Measured at base line, third (T1) and sixth (T2) months.
1.Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).
Secondary Outcome:
- Periodontal Ligament (PDL) Health using: Pocket Depth Index (PDI)
- Gingival Bleeding and Inflammation
Duration of the study:
•This study is suggested to be finished in 12 months.
- Conditions
- White Spot Lesions, Clear Aligner Appliance
- Being tested
- Application of fluoride-releasing composite, Application of conventional composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of fluoride-releasing compositeOther
using fluoride releasing composite for attachment construction
Application of conventional compositeOther
using non fluoridated composite for attachment construction
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Experimental Side) | Experimental | application of fluoride-releasing composite on the indicated side of the mouth as attachments. Receives: Other: Application of fluoride-releasing composite |
| Control Group (Control Side) | Active comparator | application of conventional composite as attachments. Receives: Other: Application of conventional composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
White Spot Lesions
Incidence and Severity of White Spot Lesions Measured at baseline, third (T1) and sixth (T2) months, by Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).
Measured: six months
Secondary outcomes (2)
Periodontal Ligament (PDL) Health
Periodontal Ligament (PDL) Health using:
- Pocket Depth Index (PDI), by periodontal probe
- 1-3 mm: Healthy or mild inflammation.
- 4-5 mm: Moderate periodontal disease.
- ≥6 mm: Severe periodontal disease with potential bone loss.
Measured: six months
Gingival Bleeding and Inflammation
Gingival Bleeding Index (GBI) Dichotomous (yes/no bleeding) no=0 yes=1
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Aug 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for White Spot LesionsStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Amer, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426432
- Sponsor's protocol ID
- Mansoura_ University
- Status last verified
- Feb 2026
- First submitted
- 20 Dec 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy: A Controlled Split-Mouth Study
- ClinicalTrials.gov ID
- NCT07426432
- Acronym / sponsor ID
- Mansoura_ University
- Conditions
- White Spot Lesions, Clear Aligner Appliance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 23 Feb 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.
Aim of this study: evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions.
Material and methods:
Type: Prospective, randomized split mouth controlled study.
Interventions:
Intervention Group (Experimental Side):
•Application of fluoride-releasing composite
Control Group (Control Side):
•Application of conventional composite
Outcome Measures:
Primary Outcome: Incidence and Severity of White Spot Lesions
Secondary Outcomes:
- Periodontal Ligament (PDL) Health
- Gingival Bleeding and Inflammation
Detailed description
Aim of the Study:
The aim of this study is to evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions (WSLs) development during clear aligner therapy in comparison to a split-mouth controlled group.
Material and methods:
Study Design:
Each participant will have one side of the mouth assigned to fluoride-releasing composite intervention as attachments, while the contralateral side will be assigned to conventional composite as attachments.
Sample size calculation:
Sample size calculation was based on effect of fluoride-releasing composite resin on prevention of White Spot Lesions during Clear Aligner Therapy: that was retrieved from most similar research Abdullah et al. Using G power program version 3.1.9.7 to calculate sample size based on effect size of 1.08 that is based on mean area of white spots, using 2-tailed test, α error = 0.05 and power = 95% , the total calculated sample size will be 24 in each group. To mitigate the potential impact of an anticipated 20% dropout rate, the recruitment target was increased to 30 patients per treatment group, aiming to ensure adequate statistical power in the final analyzed sample.
Inclusion Criteria:
- Patients aged 16-24 years.
- Good general and oral health.
- Mild dental crowding per arch (≤ 4 mm).
Exclusion Criteria:
- Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
- Patients with Cleft lip and palate.
- Previous orthodontic treatment.
- Dental fluorosis.
- Hypocalcified teeth or visible demineralization.
Interventions:
- Initial Oral Scan: A 3D oral scan of the arch to be treated will be performed using a digital intraoral scanner
- Aligner Fabrication: Aligners will be fabricated using thermoforming techniques. Intervention Group (Experimental Side): application of a fluoride-releasing composite on the indicated side of the mouth as attachments. Control Group (Control Side): application of conventional composite as attachments.
- Aligner Placement: the aligners will be fitted, and patients will wear them continuously, except during eating and brushing.
Outcome Measures:
Primary Outcome: Incidence and Severity of White Spot Lesions Measured at base line, third (T1) and sixth (T2) months.
1.Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).
Secondary Outcome:
- Periodontal Ligament (PDL) Health using: Pocket Depth Index (PDI)
- Gingival Bleeding and Inflammation
Duration of the study:
•This study is suggested to be finished in 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Experimental Side) | Experimental | Other: Application of fluoride-releasing compositeapplication of fluoride-releasing composite on the indicated side of the mouth as attachments. |
| Control Group (Control Side) | Active comparator | Other: Application of conventional compositeapplication of conventional composite as attachments. |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients aged 16-24 years.
- Good general and oral health.
- Mild dental crowding per arch (≤ 4 mm).
Key exclusion criteria (5 listed)
- Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
- Patients with Cleft lip and palate.
- Previous orthodontic treatment.
- Dental fluorosis.
- Hypocalcified teeth or visible demineralization.
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 |
|---|---|---|
| Application of fluoride-releasing compositeusing fluoride releasing composite for attachment construction | Other | Intervention Group (Experimental Side) |
| Application of conventional compositeusing non fluoridated composite for attachment construction | Other | Control Group (Control Side) |
Primary outcome
White Spot Lesions
Time frame: six months
Incidence and Severity of White Spot Lesions Measured at baseline, third (T1) and sixth (T2) months, by Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).
2 secondary outcomes
Periodontal Ligament (PDL) Health
Time frame: six months
Gingival Bleeding and Inflammation
Time frame: six months
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 23 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of fluoride-releasing composite and Application of conventional composite in people with White Spot Lesions and Clear Aligner Appliance, run by Mansoura 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 3 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: under way, not looking for participants, as of the sponsor's last update on 23 Feb 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?
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?
White Spot Lesions (time frame: six 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 23 Feb 2026.