Clinical trial NCT06798870: White Spot Lesions Development in Mixed Dentition Patients
Official title: Investigation of White Spot Lesions Development During Management of Mixed Dentition Patients with Anterior Functional Shift
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anterior Functional Shift
Keywords: white spot lesion
mixed dentition patients
clear aligner
anterior functional shift
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 36
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: 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

Primary outcomes:
measure: development of white spot lesion
timeFrame: 4 months
Secondary outcomes:
measure: the highly incidence of white spot lesion in upper and lower teeth
timeFrame: 4 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: Egypt, Mansoura university, faculty of Dentistry, orthodontic department
name: NEHAL F Albelasy, PhD
role: PRINCIPAL_INVESTIGATOR
References: