Active — Not RecruitingNot Applicable

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

Egypt25 participantsStarted 2025-06-25

Plain-language 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)

Who can participate

Age range16 Years – 24 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Incidence and Severity of White Spot Lesions

Timeframe: Six months

Trial details

NCT IDNCT07319884

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-25

View on ClinicalTrials.gov More White Spot Lesion trials