White Spot Lesion of ToothNCT07368296
Impact of Lingual Attachment on WSL Development in Clear Aligner Patients: A Randomized Controlled Clinical Trial
A study testing Lingual attachment participants in people with White Spot Lesion of Tooth, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
White spot lesions (WSLs) are a common esthetic complication during orthodontic treatment. While clear aligners (CAs) generally reduce WSL risk compared to fixed appliances, composite attachments remain plaque-retentive sites. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth
- What is being tested?
- Lingual attachment participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteJordan
- Study dates
- 2 Feb 2025to May 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically fit young adults
- The patient should have mild to moderate crowding or spacing of teeth.
- The treatment plan should be non-extraction.
- Patients should have optimum oral hygiene before beginning the treatment.
- The patient may have a maximum of three teeth with either fillings or dental prostheses.
- (According to the British national institute of health, NIH 2016).
Who cannot join
- Patients with defective enamel, generalized enamel disorder, or extensive dental restorations.
- Patients with syndromes or orofacial anomalies.
- Patients with salivary gland diseases or taking medications that may affect oral flora or salivary functions.
- Patients who are pregnant or diabetic.
- Patients use mouth rinses or any extra form of fluoride other than toothpaste.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Lingual Attachment Placement on White Spot Lesion Development in Clear Aligner Orthodontic Patients : A Randomized Controlled Clinical Trial
White spot lesions (WSLs) are a common esthetic complication during orthodontic treatment. While clear aligners (CAs) generally reduce WSL risk compared to fixed appliances, composite attachments remain plaque-retentive sites. This two-arm clinical trial investigated the effect of shifting attachments to lingual surfaces on WSL development.
Read the detailed description
A randomized controlled trial was conducted on 52 patients (18-35 years) undergoing CA therapy. Participants were allocated to two groups (n=26) for each: conventional buccal attachments (control) and lingual/palatal attachments (intervention). WSLs and plaque were assessed at baseline (T0) and six months (T1) using quantitative light-induced fluorescence (QLF). Outcomes included lesion area (pixels), mean fluorescence loss (ΔF), maximum depth (ΔFmax), and plaque index (ΔR30). Statistical analysis employed paired and independent t-tests, chi-square, and multivariable regression (α<0.05).
- Conditions
- White Spot Lesion of Tooth
- Being tested
- Lingual attachment participants
- Keywords
- Lingual attachments, Buccal attachments, White spot lesions, Quantitative light induced fluorescence, Clear aligner therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lingual attachment participantsOther
WSL were measured on tooth surfaces of orthodontic patients wearing clear aligners with lingual attachments
| Study group | Role | What they receive |
|---|---|---|
| Lingual attachment participants | Active comparator | In this group composite attachments were placed on the lingual/palatal surfaces of teeth for clear aligner therapy Receives: Other: Lingual attachment participants |
| Buccal attachment participants | Active comparator | In this group composite attachments were placed on the buccal surfaces of teeth for clear aligner therapy Receives: Other: Lingual attachment participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
White spot lesion area
Lesion area measured in pixels
Measured: Before treatment and after 6 months
Delta F
Loss of fluorescence which reflects loss in minerals
Measured: Before treatment and after 6 months
Delta F max
Measures the deepest point of the lesion
Measured: Before treatment and after 6 months
Secondary outcomes (1)
Plaque measurement
It measures the amount of plaque on tooth surfaces
Measured: Before treatment and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start2 Feb 2025
- Primary completionFeb 2027 (estimated)
- Study completionMay 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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 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
- NCT07368296
- Sponsor's protocol ID
- JUST20240550
- Status last verified
- Mar 2026
- First submitted
- 18 Jan 2026
- Last updated
- 31 Mar 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 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Lingual Attachment Placement on White Spot Lesion Development in Clear Aligner Orthodontic Patients : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07368296
- Acronym / sponsor ID
- JUST20240550
- Conditions
- White Spot Lesion of Tooth
- Keywords
- Lingual attachments, Buccal attachments, White spot lesions, Quantitative light induced fluorescence, Clear aligner therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Jan 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.
White spot lesions (WSLs) are a common esthetic complication during orthodontic treatment. While clear aligners (CAs) generally reduce WSL risk compared to fixed appliances, composite attachments remain plaque-retentive sites. This two-arm clinical trial investigated the effect of shifting attachments to lingual surfaces on WSL development.
Detailed description
A randomized controlled trial was conducted on 52 patients (18-35 years) undergoing CA therapy. Participants were allocated to two groups (n=26) for each: conventional buccal attachments (control) and lingual/palatal attachments (intervention). WSLs and plaque were assessed at baseline (T0) and six months (T1) using quantitative light-induced fluorescence (QLF). Outcomes included lesion area (pixels), mean fluorescence loss (ΔF), maximum depth (ΔFmax), and plaque index (ΔR30). Statistical analysis employed paired and independent t-tests, chi-square, and multivariable regression (α<0.05).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lingual attachment participants | Active comparator | Other: Lingual attachment participantsIn this group composite attachments were placed on the lingual/palatal surfaces of teeth for clear aligner therapy |
| Buccal attachment participants | Active comparator | Other: Lingual attachment participantsIn this group composite attachments were placed on the buccal surfaces of teeth for clear aligner therapy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Medically fit young adults
- The patient should have mild to moderate crowding or spacing of teeth.
- The treatment plan should be non-extraction.
- Patients should have optimum oral hygiene before beginning the treatment.
- The patient may have a maximum of three teeth with either fillings or dental prostheses.
Key exclusion criteria (5 listed)
- Patients with defective enamel, generalized enamel disorder, or extensive dental restorations.
- Patients with syndromes or orofacial anomalies.
- Patients with salivary gland diseases or taking medications that may affect oral flora or salivary functions.
- Patients who are pregnant or diabetic.
- Patients use mouth rinses or any extra form of fluoride other than toothpaste.
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 |
|---|---|---|
| Lingual attachment participantsWSL were measured on tooth surfaces of orthodontic patients wearing clear aligners with lingual attachments | Other | Buccal attachment participants, Lingual attachment participants |
Primary outcome
White spot lesion area
Time frame: Before treatment and after 6 months
Lesion area measured in pixels
Delta F
Time frame: Before treatment and after 6 months
Loss of fluorescence which reflects loss in minerals
Delta F max
Time frame: Before treatment and after 6 months
Measures the deepest point of the lesion
1 secondary outcome
Plaque measurement
Time frame: Before treatment and after 6 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 31 Mar 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 Lingual attachment participants in people with White Spot Lesion of Tooth, run by Jordan University of Science and Technology at 1 site in Jordan.
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 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 31 Mar 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 Jordan. 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 lesion area (time frame: Before treatment and after 6 months). The study lists 3 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 31 Mar 2026.