White Spot Lesions Development in Mixed Dentition Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-02

Study Completion Date

2025-03-15

Brief Summary

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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.

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Detailed Description

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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

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Anterior Functional Shift

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

blinding the data

Study Groups

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Removable inclined plane group

removable appliance for correcting anterior crossbite

Group Type ACTIVE_COMPARATOR

removable appliances

Intervention Type DEVICE

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

clear aligner

clear aligner appliance for correcting anterior crossbite

Group Type ACTIVE_COMPARATOR

removable appliances

Intervention Type DEVICE

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

Interventions

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removable appliances

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes