NCT07426432

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

Evaluate the Effect of Fluoride-Releasing Composite Resin on Prevention of White Spot Lesions During Clear Aligner Therapy: A Controlled Split-Mouth Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 16 Years – 24 Years
• Healthy volunteers: Accepted

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

Detailed description

Aim of the Study: The aim of this study is to evaluate the effect of fluoride-releasing composite resin as attachments on prevention of white spot lesions (WSLs) development during clear aligner therapy in comparison to a split-mouth controlled group. Material and methods: Study Design: Each participant will have one side of the mouth assigned to fluoride-releasing composite intervention as attachments, while the contralateral side will be assigned to conventional composite as attachments. Sample size calculation: Sample size calculation was based on effect of fluoride-releasing composite resin on prevention of White Spot Lesions during Clear Aligner Therapy: that was retrieved from most similar research Abdullah et al. Using G power program version 3.1.9.7 to calculate sample size based on effect size of 1.08 that is based on mean area of white spots, using 2-tailed test, α error = 0.05 and power = 95% , the total calculated sample size will be 24 in each group. To mitigate the potential impact of an anticipated 20% dropout rate, the recruitment target was increased to 30 patients per treatment group, aiming to ensure adequate statistical power in the final analyzed sample. 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. Interventions: 1. Initial Oral Scan: A 3D oral scan of the arch to be treated will be performed using a digital intraoral scanner 2. Aligner Fabrication: Aligners will be fabricated using thermoforming techniques. Intervention Group (Experimental Side): application of a fluoride-releasing composite on the indicated side of the mouth as attachments. Control Group (Control Side): application of conventional composite as attachments. 3. Aligner Placement: the aligners will be fitted, and patients will wear them continuously, except during eating and brushing. Outcome Measures: Primary Outcome: Incidence and Severity of White Spot Lesions Measured at base line, third (T1) and sixth (T2) months. 1.Laser fluorescence (DIAGNOdent), lesion defined as having a numerical score equal to or higher than (14). Secondary Outcome: 1. Periodontal Ligament (PDL) Health using: Pocket Depth Index (PDI) 2. Gingival Bleeding and Inflammation Duration of the study: •This study is suggested to be finished in 12 months.

Conditions

• White Spot Lesions
• Clear Aligner Appliance

Interventions

Type	Name	Description
OTHER	Application of fluoride-releasing composite	using fluoride releasing composite for attachment construction
OTHER	Application of conventional composite	using non fluoridated composite for attachment construction

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Egypt