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

N/AActive Not RecruitingNCT07368296

Jordan University of Science and Technology52 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

White Spot Lesion of Tooth

Interventions

Lingual attachment participantsOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

postgraduate orthodontic clinics at JUST

Irbid, Jordan

Outcomes

Primary Outcomes

White spot lesion area

Lesion area measured in pixels

Time frame: Before treatment and after 6 months

Delta F

Loss of fluorescence which reflects loss in minerals

Time frame: Before treatment and after 6 months

Delta F max

Measures the deepest point of the lesion

Time frame: Before treatment and after 6 months

Secondary Outcomes

Plaque measurement

It measures the amount of plaque on tooth surfaces

Time frame: Before treatment and after 6 months

Data from ClinicalTrials.gov

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