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Clinical Trials in Egypt / NCT07426432
Active, not recruiting Not applicable

Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy

NCT07426432 · tracked via the Priya Life Science Egypt tracker
Sponsor
Mansoura University
Phase
Not applicable
Started
2025-08-01
Last updated
2026-02-23

Condition(s) studied

White Spot LesionsClear Aligner Appliance

Investigational drug(s) / intervention(s)

Application of fluoride-releasing compositeApplication of conventional composite

Application of fluoride-releasing composite: using fluoride releasing composite for attachment construction

Application of conventional composite: using non fluoridated composite for attachment construction

Study summary

Aim of this study: evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions.

Material and methods:

Type: Prospective, randomized split mouth controlled study.

Interventions:

Intervention Group (Experimental Side):

•Application of fluoride-releasing composite

Control Group (Control Side):

•Application of conventional composite

Outcome Measures:

Primary Outcome: Incidence and Severity of White Spot Lesions

Secondary Outcomes:

1. Periodontal Ligament (PDL) Health
2. Gingival Bleeding and Inflammation

Eligibility

Sex
ALL
Min age
16 Years
Max age
24 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Patients aged 16-24 years. * Good general and oral health. * Mild dental crowding per arch (≤ 4 mm). Exclusion Criteria: * 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.

Primary outcome measure(s)

  • White Spot Lesions — six months
    Incidence and Severity of White Spot Lesions Measured at baseline, third (T1) and sixth (T2) months, by Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14).

Trial sites (1)

FacilityCityRegionStatus
Mansoura University Al Mansurah Egypt

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Other trials for the same condition

"Clinical Evaluation of Self-Assembling Peptides Versus Tri-Calcium Phosphate Based Varnish in Treatment of White Spot Lesions; Split-Mouth Randomized Clinical Trial" Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07426432 on ClinicalTrials.gov ↗ ← All trials in Egypt