White Spot LesionNCT06882304
PREVALENCE OF WHITE SPOT LESIONS IN ENAMEL AFTER ORTHODONTIC TREATMENT IN YOUNG ADULTS
An observational study of White Spot Lesion, run by Cairo University.
Trial summary
The aim of the study is to measure prevalence of enamel white spot lesions in enamel in young adults after orthodontic treatment. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- orthodontic treatment
- How many people
- 368 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Oct 2027
- Phase
- Observational
- 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 18 to 30 years
- All sexes
- Adult
Study population: 1. Patients whose age between 18-30 years old consulting in the outpatient clinic. 2. Provide informed consent. 3. Co-operative patients approving to participate in the trial. 4. Both sexes are included 5. Egyptian
Who may be able to join
- Patients whose age between 18-30 years old consulting in the outpatient clinic.
- Provide informed consent.
- Co-operative patients approving to participate in the trial.
- Both sexes are included
- Egyptian -
Who cannot join
- Patients under or over this age group.
- Patients with other developmental defect, such as; fluorosis, amelogenesis imperfecta and syndromes associated with enamel formation defects.
- Patient with MIH .
- Refuse to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PREVALENCE OF WHITE SPOT LESIONS IN ENAMEL AFTER ORTHODONTIC
The aim of the study is to measure prevalence of enamel white spot lesions in enamel in young adults after orthodontic treatment.
- Conditions
- White Spot Lesion
- Being tested
- orthodontic treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthodontic treatmentOther
young adult after orthodontic treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of white spot lesions in enamel after orthodontic treatment in young adults
to measure the prevalence of enamel white spot lesions in enamel in young adults after orthodontic treatment.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYATELLAH MOHAMED OSMAN MOHAMED MOHAMED GHONIMA, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882304
- Sponsor's protocol ID
- WSL
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.
PubMed 21208070Akin M, Tezcan M, Ileri Z, Ayhan F. Incidence of white spot lesions among patients treated with self- and conventional ligation systems. Clin Oral Investig. 2015 Jul;19(6):1501-6. doi: 10.1007/s00784-014-1382-3. Epub 2014 Dec 13.
PubMed 25502686
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVALENCE OF WHITE SPOT LESIONS IN ENAMEL AFTER ORTHODONTIC
- ClinicalTrials.gov ID
- NCT06882304
- Acronym / sponsor ID
- WSL
- Conditions
- White Spot Lesion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 18 Mar 2025 (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 the study is to measure prevalence of enamel white spot lesions in enamel in young adults after orthodontic treatment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- 1. Patients whose age between 18-30 years old consulting in the outpatient clinic. 2. Provide informed consent. 3. Co-operative patients approving to participate in the trial. 4. Both sexes are included 5. Egyptian
Key inclusion criteria (5 listed)
- Patients whose age between 18-30 years old consulting in the outpatient clinic.
- Provide informed consent.
- Co-operative patients approving to participate in the trial.
- Both sexes are included
- Egyptian -
Key exclusion criteria (4 listed)
- Patients under or over this age group.
- Patients with other developmental defect, such as; fluorosis, amelogenesis imperfecta and syndromes associated with enamel formation defects.
- Patient with MIH .
- Refuse 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 |
|---|---|---|
| orthodontic treatmentyoung adult after orthodontic treatment | Other | – |
Primary outcome
Prevalence of white spot lesions in enamel after orthodontic treatment in young adults
Time frame: baseline
to measure the prevalence of enamel white spot lesions in enamel in young adults after orthodontic treatment.
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 18 Mar 2025.
- Background: PubMed 21208070Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.
- Background: PubMed 25502686Akin M, Tezcan M, Ileri Z, Ayhan F. Incidence of white spot lesions among patients treated with self- and conventional ligation systems. Clin Oral Investig. 2015 Jul;19(6):1501-6. doi: 10.1007/s00784-014-1382-3. Epub 2014 Dec 13.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of White Spot Lesion, run by Cairo University.
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 4 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Ayatellah Mohamed, Master candidate (01004600321, ayatellah.ossman@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of white spot lesions in enamel after orthodontic treatment in young adults (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06882304, which also lists 2 linked publications.
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 18 Mar 2025.