White Spot LesionNCT04107012
Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment
A study testing Orthodontic treatment with clear aligner in people with White Spot Lesion, run by Jordan University of Science and Technology.
Trial summary
Development of white spot lesions (enamel demineralization) will be evaluated quantitatively during clear aligner orthodontic treatment compared to conventional fixed appliances using quantitative light induced fluorescence (QLF) Read more about this study
- Who is it for?
- Ages 17 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion
- What is being tested?
- Orthodontic treatment with clear aligner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2018
- 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 17 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy patients from both genders aged (17 - 24 years).
- Class I malocclusion with mild to moderate crowding (≤ 5 mm).
- Non-extraction treatment plan.
- Optimum oral Hygiene before treatment with no signs of gingivitis and/or periodontitis.
- Maximum of 3 restored teeth.
- Absence of defective enamel formation in the form of hypocalcification or hypoplasia.
Who cannot join
- -Patients with poor oral hygiene, defective enamel, extensive restorations and salivary glands diseases were excluded.
About this study
Official title: Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment With QLF Compared to Conventional Fixed Appliances: a Randomized Clinical Trial
Development of white spot lesions (enamel demineralization) will be evaluated quantitatively during clear aligner orthodontic treatment compared to conventional fixed appliances using quantitative light induced fluorescence (QLF)
Read the detailed description
White spot lesion (WSL) may develop around fixed orthodontic appliances. With clear aligners, however, the issue is not controversial. WSL will be monitored in 2 groups of patients; one group using clear aligners and one group wearing fixed orthodontic appliances for 3 months. QLF images will be taken before treatment (T0) and 3 months after commencement of the treatment (T1). The results will be compared between the two groups
- Conditions
- White Spot Lesion
- Being tested
- Orthodontic treatment with clear aligner
- Keywords
- White spot lesion, QLF, Clear aligners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic treatment with clear alignerDevice
Included orthodontic treatment with clear aligner (eon Aligners)
| Study group | Role | What they receive |
|---|---|---|
| Clear Aligner | Experimental | Group 1 treated with clear aligners Receives: Device: Orthodontic treatment with clear aligner |
| Fixed appliance | Active comparator | Group 2 treated with conventional fixed appliances Receives: Device: Orthodontic treatment with clear aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta F
Incideance of Fluorescence loss
Measured: 3 months
Lesion area
Incidence of the white spot lesion area
Measured: 3 months
Secondary outcomes (2)
Number of new lesions
The number of newly developed white spot lesion during orthodontic treatment
Measured: 3 months
ΔR30
Rate of plaque on tooth surfaces
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study startSep 2016
- Primary completionJan 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for White Spot LesionStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107012
- Sponsor's protocol ID
- JUST20160295
- Status last verified
- Sep 2019
- First submitted
- 14 Jul 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Albhaisi Z, Al-Khateeb SN, Abu Alhaija ES. Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 May;157(5):594-601. doi: 10.1016/j.ajodo.2020.01.004.
PubMed 32354432
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment With QLF Compared to Conventional Fixed Appliances: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04107012
- Acronym / sponsor ID
- JUST20160295
- Conditions
- White Spot Lesion
- Keywords
- White spot lesion, QLF, Clear aligners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 27 Sep 2019 (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.
Development of white spot lesions (enamel demineralization) will be evaluated quantitatively during clear aligner orthodontic treatment compared to conventional fixed appliances using quantitative light induced fluorescence (QLF)
Detailed description
White spot lesion (WSL) may develop around fixed orthodontic appliances. With clear aligners, however, the issue is not controversial. WSL will be monitored in 2 groups of patients; one group using clear aligners and one group wearing fixed orthodontic appliances for 3 months. QLF images will be taken before treatment (T0) and 3 months after commencement of the treatment (T1). The results will be compared between the two groups
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear Aligner | Experimental | Device: Orthodontic treatment with clear alignerGroup 1 treated with clear aligners |
| Fixed appliance | Active comparator | Device: Orthodontic treatment with clear alignerGroup 2 treated with conventional fixed appliances |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Healthy patients from both genders aged (17 - 24 years).
- Class I malocclusion with mild to moderate crowding (≤ 5 mm).
- Non-extraction treatment plan.
- Optimum oral Hygiene before treatment with no signs of gingivitis and/or periodontitis.
- Maximum of 3 restored teeth.
Key exclusion criteria (1 listed)
- -Patients with poor oral hygiene, defective enamel, extensive restorations and salivary glands diseases were excluded.
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 treatment with clear alignerIncluded orthodontic treatment with clear aligner (eon Aligners) | Device | Clear Aligner, Fixed appliance |
Primary outcome
Delta F
Time frame: 3 months
Incideance of Fluorescence loss
Lesion area
Time frame: 3 months
Incidence of the white spot lesion area
2 secondary outcomes
Number of new lesions
Time frame: 3 months
ΔR30
Time frame: 3 months
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 27 Sep 2019.
- Derived from this study: PubMed 32354432Albhaisi Z, Al-Khateeb SN, Abu Alhaija ES. Enamel demineralization during clear aligner orthodontic treatment compared with fixed appliance therapy, evaluated with quantitative light-induced fluorescence: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 May;157(5):594-601. doi: 10.1016/j.ajodo.2020.01.004.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic treatment with clear aligner in people with White Spot Lesion, run by Jordan University of Science and Technology.
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 1 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 27 Sep 2019. 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?
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?
Delta F (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT04107012, which also lists 1 linked publication.
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 27 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.