NCT06798870

White Spot Lesions Development in Mixed Dentition Patients

Investigation of White Spot Lesions Development During Management of Mixed Dentition Patients with Anterior Functional Shift

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 9 Years – 12 Years
• Healthy volunteers: Accepted

Summary

36 patient will be divided into two equal groups. one for removable inclined plane while the other will be treated using clear aligner appliances. evaluation of the white spot lesion will be accumplished for all patients clinically before anr after completion of treatment.

Detailed description

The sample size was calculated using G\*Power (Version 3.1.9.4; Germany) and designed to have a power of 82% assuming type I statistical error of 5% and one-tailed statistical test based on Azeem and Hamid.13 The calculated sample was 15 patients in each group. The sample will be increased to include 36 patients: 18 patients per group for a 20% expected loss. Patients with the age range of 9 to 12 years will be selected for the study. All patients and their parents will be informed of the procedures and will sign the informed consent. Patients who had periodontal diseases, bone resorption cleft lip and palate deformities, orofacial syndrome, hypoplastic enamel defects, and multiple restorations on the facial surfaces or unable to maintain good oral hygiene will be excluded from the study. All patients will be randomly allocated into two groups according to the management protocol: inclined plane and clear aligner. The patients will be examined for any white spot lesion on the labial surface of the teeth in the upper and lower jaws clinically and using lateral and frontal intraoral photographs immediately before treatment and monthly along the treatment procedures. Each tooth will be evaluated, and the total lesions count will be recorded for each patient. All patients will be instructed to maintain good oral hygiene using fluoridated toothpaste daily. Statistical analysis: The incidence of the WSL in each tooth and the total lesions count will be calculated for each patient. These data will be collected and subjected to the appropriate statistical tests using the SPSS version 20.0 software for Windows (IBM, USA).

Conditions

• Anterior Functional Shift

Interventions

Type	Name	Description
DEVICE	removable appliances	removable appliances; clear aligner and removable inclined plane, for correcting anterior crossbite vin mixed dentition patient

Timeline

• Start date: 2024-07-02
• Primary completion: 2025-01-30
• Completion: 2025-03-15
• First posted: 2025-01-29
• Last updated: 2025-01-29

Locations

1 site across 1 country: Egypt