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NCT Number: NCT07368296

Impact of Lingual Attachment on WSL Development in Clear Aligner 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

postgraduate orthodontic clinics at JUST

Irbid, 22110, Jordan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lingual attachment participants

Other

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

Primary outcomes

  1. White spot lesion area

    Time frame: Before treatment and after 6 months

    Lesion area measured in pixels

  2. Delta F

    Time frame: Before treatment and after 6 months

    Loss of fluorescence which reflects loss in minerals

  3. Delta F max

    Time frame: Before treatment and after 6 months

    Measures the deepest point of the lesion

Secondary outcomes

  1. Plaque measurement

    Time frame: Before treatment and after 6 months

    It measures the amount of plaque on tooth surfaces

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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