Active, Not Recruiting

NCT Number: NCT06798870

White Spot Lesions Development in Mixed Dentition Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Anterior Functional Shift

Age range

9 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Al Mansurah, 34455, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

removable appliances

Device

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

Primary outcomes

development of white spot lesion

Time frame: 4 months

examination of the teeth clinically for detecting white spot lesion

Secondary outcomes

the highly incidence of white spot lesion in upper and lower teeth

Time frame: 4 months

counting the mostly affected teeth by white spot lesion

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: WSL

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jan 29, 2025
Registry last updated: Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.