Trials / Completed
CompletedNCT05764187
Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets
Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets Evaluated With Quantitative Light-induced Fluorescence: A Randomized Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Jordan University of Science and Technology · Academic / Other
- Sex
- All
- Age
- 18 Years – 35 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Orthodontic fixed appliance therapy | Follow up of white spot lesion development using quantitative light induced fluorescence in patients bonded with ceramic brackets versus patients bonded with conventional metal brackets |
Timeline
- Start date
- 2021-12-28
- Primary completion
- 2022-07-07
- Completion
- 2022-12-01
- First posted
- 2023-03-10
- Last updated
- 2025-07-11
Locations
1 site across 1 country: Jordan
Source: ClinicalTrials.gov record NCT05764187. Inclusion in this directory is not an endorsement.