Skip to main content
OpenTrials
Completed

NCT Number: NCT05764187

Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Postgraduate Teaching Dental Clinics/JUST

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Orthodontic fixed appliance therapy

Other

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

Primary outcomes

  1. Lesion area

    Time frame: 4 months

    Surface area of the lesion measured in Pixels

  2. Mean fluorescence loss ∆F(%)

    Time frame: 4 months

    Mean lesion fluorescence loss reflecting mineral loss measured in percent

  3. Maximum fluorescence loss ∆Fmax(%)

    Time frame: 4 months

    Deepest point of the lesion

  4. Incidence of white spot lesions

    Time frame: 4 months

    The number of newly developed white spot lesions

Secondary outcomes

  1. Plaque measurement

    Time frame: 4 months

    Amount of plaque around the orthodontic fixed appliance

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets Evaluated With Quantitative Light-induced Fluorescence: A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 10, 2023
Registry last updated
Jul 11, 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.

Published trials that share one or more normalized conditions with this study.