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Impact of Lingual Attachment on WSL Development in Clear Aligner Patients: A Randomized Controlled Clinical Trial

Impact of Lingual Attachment Placement on White Spot Lesion Development in Clear Aligner Orthodontic Patients : A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07368296
Enrollment
52
Registered
2026-01-26
Start date
2025-02-02
Completion date
2027-05-01
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion of Tooth

Keywords

Lingual attachments, Buccal attachments, White spot lesions, Quantitative light induced fluorescence, Clear aligner therapy

Brief 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. 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).

Interventions

OTHERLingual attachment participants

WSL were measured on tooth surfaces of orthodontic patients wearing clear aligners with lingual attachments

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
White spot lesion areaBefore treatment and after 6 monthsLesion area measured in pixels
Delta FBefore treatment and after 6 monthsLoss of fluorescence which reflects loss in minerals
Delta F maxBefore treatment and after 6 monthsMeasures the deepest point of the lesion

Secondary

MeasureTime frameDescription
Plaque measurementBefore treatment and after 6 monthsIt measures the amount of plaque on tooth surfaces

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026