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

March 25, 2026 updated by: Jordan University of Science and Technology

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • postgraduate orthodontic clinics at JUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lingual attachment participants
In this group composite attachments were placed on the lingual/palatal surfaces of teeth for clear aligner therapy
Other: Lingual attachment participants
WSL were measured on tooth surfaces of orthodontic patients wearing clear aligners with lingual attachments
Active Comparator: Buccal attachment participants
In this group composite attachments were placed on the buccal surfaces of teeth for clear aligner therapy
Other: Lingual attachment participants
WSL were measured on tooth surfaces of orthodontic patients wearing clear aligners with lingual attachments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
White spot lesion area
Time Frame: Before treatment and after 6 months
Lesion area measured in pixels
Before treatment and after 6 months
Delta F
Time Frame: Before treatment and after 6 months
Loss of fluorescence which reflects loss in minerals
Before treatment and after 6 months
Delta F max
Time Frame: Before treatment and after 6 months
Measures the deepest point of the lesion
Before treatment and after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque measurement
Time Frame: Before treatment and after 6 months
It measures the amount of plaque on tooth surfaces
Before treatment and after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JUST20240550

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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