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

NCT07319884 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-06

No results posted yet for this study

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

Interventions

OTHER

White spot lesion with fluoride varnish application

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

OTHER

White spot lesion without fluoride varnish application

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

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
24 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2027-01-25
Completion
2027-02-01

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07319884 on ClinicalTrials.gov