NCT07368296

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Feb 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Feb 2025May 2027

Study Start

First participant enrolled

February 2, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

January 18, 2026

Last Update Submit

March 25, 2026

Conditions

White Spot Lesion of Tooth

Keywords

Lingual attachmentsBuccal attachmentsWhite spot lesionsQuantitative light induced fluorescenceClear aligner therapy

Outcome Measures

Primary Outcomes (3)

  • White spot lesion area

    Lesion area measured in pixels

    Before treatment and after 6 months

  • Delta F

    Loss of fluorescence which reflects loss in minerals

    Before treatment and after 6 months

  • Delta F max

    Measures the deepest point of the lesion

    Before treatment and after 6 months

Secondary Outcomes (1)

  • Plaque measurement

    Before treatment and after 6 months

Study Arms (2)

Lingual attachment participants

ACTIVE COMPARATOR

In this group composite attachments were placed on the lingual/palatal surfaces of teeth for clear aligner therapy

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

Other: Lingual attachment participants

Interventions

Lingual attachment participantsOTHER

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

Buccal attachment participantsLingual attachment participants

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

postgraduate orthodontic clinics at JUST

Irbid, 22110, Jordan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2026

First Posted

January 26, 2026

Study Start

February 2, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

JO(1)