Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07426432
Brief 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.
Study:
NCT07426432
Study Brief:
Protocol Section:
NCT07426432