Clinical trial NCT05764187: Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets
Official title: Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets Evaluated With Quantitative Light-induced Fluorescence: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: White Spot Lesion of Tooth
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two parallel arm randomized clinical trial
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of this study was to investigate the relation between ceramic brackets and the development of white spot lesions (WSLs) compared to that associated with conventional metal brackets.

Detailed description: Objectives : The main objective of this study was to investigate the relation between ceramic brackets and the development of WSL compared to that associated with conventional metal brackets.

Study design: Randomized 2-parallel arm clinical trial. Materials and methods: Quantitative light induced fluorescence (QLF) images were taken for the two randomly allocated groups (Ceramic group, n=26; Metal group, n=25) of patients at T0: before the start of treatment; T1: after 2 months and T2: at 4 months after treatment). The QLF images were analyzed; Primary outcome measures: The lesion area (Pixels) and Mean amount of fluorescence loss (∆F)% and the number of newly developed lesions. Secondary outcome: Maximum fluorescence loss (∆F-Max)% and plaque surface area (∆R 30)%. Means and standard deviations for all the measured parameters at T0, T1 and T2 were calculated. Split plot analysis of variance (SPANOVA) test was used to determine the changes within each group at the different time intervals, and between the two groups. Chi square was used to compare between the two groups regarding the number of new lesions during the treatment. P value was set at 0.05 level.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects seeking orthodontic treatment with mild-to-moderate crowding (not exceeding 5 mm)
* No previous orthodontic treatment
* Optimum oral hygiene
* Maximum of 3 restored teeth
* Absence of defective enamel formation in the form of hypocalcification or hypoplasia.

Exclusion Criteria:

* Subjects with poor oral hygiene
* Defective enamel
* Patients with syndromes and Oro-facial anomalies or salivary glands diseases

Primary outcomes:
measure: Lesion area
timeFrame: 4 months
measure: Mean fluorescence loss ∆F(%)
timeFrame: 4 months
measure: Maximum fluorescence loss ∆Fmax(%)
timeFrame: 4 months
measure: Incidence of white spot lesions
timeFrame: 4 months
Secondary outcomes:
measure: Plaque measurement
timeFrame: 4 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Postgraduate Teaching Dental Clinics/JUST
Study officials:
affiliation: Faculty of Dentistry/Jordan University of Science and Technology
name: Susan Al-Khateeb, Professor
role: PRINCIPAL_INVESTIGATOR
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