Skip to content

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06798870
Acronym
WSL
Enrollment
36
Registered
2025-01-29
Start date
2024-07-02
Completion date
2025-03-15
Last updated
2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Functional Shift

Keywords

white spot lesion, mixed dentition patients, clear aligner, anterior functional shift

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).

Interventions

DEVICEremovable appliances

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

blinding the data

Eligibility

Sex/Gender
ALL
Age
9 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
development of white spot lesion4 monthsexamination of the teeth clinically for detecting white spot lesion

Secondary

MeasureTime frameDescription
the highly incidence of white spot lesion in upper and lower teeth4 monthscounting the mostly affected teeth by white spot lesion

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026