White Spot Lesions Development in Mixed Dentition Patients (WSL)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Functional Shift
• Intervention / Treatment: Device: removable appliances

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).

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Mansoura, Egypt, 34455
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with the age range of 9 to 12 years with anterior crossbite will be selected for the study

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Removable inclined plane group; removable appliance for correcting anterior crossbite	Device: removable appliances; removable appliances; clear aligner and removable inclined plane, for correcting anterior crossbite vin mixed dentition patient
Active Comparator: clear aligner; clear aligner appliance for correcting anterior crossbite	Device: removable appliances; removable appliances; clear aligner and removable inclined plane, for correcting anterior crossbite vin mixed dentition patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
development of white spot lesion	examination of the teeth clinically for detecting white spot lesion	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the highly incidence of white spot lesion in upper and lower teeth	counting the mostly affected teeth by white spot lesion	4 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: NEHAL F Albelasy, PhD, Egypt, Mansoura university, faculty of Dentistry, orthodontic department

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: white spot lesion; clear aligner; mixed dentition patients; anterior functional shift
• Other Study ID Numbers: A0207024OR (Other Identifier: A0207024OR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No