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

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

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.

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.