The Role of Fluoride Varnish Application in Preventing White Spot Lesions During Clear Aligner Treatment: A Controlled Split-Mouth Study

NCT07319884 | Active Not Recruiting

• 1 other identifier: Mansoura-university
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

aim of study: is to compare the effect of the fluoride varnish application on the prevention of white spot lesions (WSLs) during clear aligner therapy Design Details: Each participant will have one side of the mouth assigned to the fluoride varnish intervention, while the contralateral side will serve as the control without fluoride varnish. Outcomes: Primary outcome: Incidence and Severity of White Spot Lesions Measured before and after six months using Laser fluorescence (DIAGNOdent) Secondary Outcome: Periodontal Ligament (PDL) Health using pocket Depth Index (PDI) Gingival Bleeding and Inflammation using bleeding on Probing Index (BOP)

Conditions

White Spot Lesion

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of White Spot Lesions

  Incidence and Severity of White Spot Lesions Measured before and after six months using Laser fluorescence (DIAGNOdent)

  Six months

Secondary Outcomes (2)

• Periodontal Ligament (PDL) Health

  Six moths

• Gingival Bleeding and Inflammation

  Six months

Study Arms (2)

White spot lesion with fluoride varnish application during clear Aligner therapy

EXPERIMENTAL

Intervention Group (Test Side): • Application of a preventive fluoride varnish on the indicated side of the mouth before clear aligner fitting.

Other: White spot lesion with fluoride varnish application

White spot lesion without fluoride varnish application during clear Aligner therapy

ACTIVE COMPARATOR

Control Group (Control Side): No application of fluoride varnish.

Other: White spot lesion without fluoride varnish application

Interventions

White spot lesion without fluoride varnish application OTHER

No fluoride varnish application at the cervical third of the labial surface or around the attachment if present

White spot lesion without fluoride varnish application during clear Aligner therapy

White spot lesion with fluoride varnish application OTHER

Application of fluoride varnish at the cervical third of labial surface or around the attachment if present

White spot lesion with fluoride varnish application during clear Aligner therapy

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients aged 16-24 years.
• Good general and oral health.
• Mild dental crowding per arch (≤ 4 mm).
• Eruption of all permanent dention excluding third molar

You may not qualify if:

• Allergy to fluoride material
• Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
• Patients with Cleft lip and palate
• Previous orthodontic treatment
• dental fluorosis.
• hypocalcified teeth or visible demineralization

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of dentistry Mansoura University

Al Mansurah, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist Jalal-Alshami

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 6, 2026
• Study Start: June 25, 2025
• Primary Completion (Estimated): January 25, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

EG (1)