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

July 8, 2025 updated by: Jordan University of Science and Technology

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

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.

Study Overview

Status

Completed

Conditions

White Spot Lesion of Tooth

Intervention / Treatment

Other: Orthodontic fixed appliance therapy

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Jordan
- - Irbid, Jordan, 22110
    - Postgraduate Teaching Dental Clinics/JUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ceramic orthodontic brackets Patients bonded with ceramic brackets for orthodontic treatment	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
Active Comparator: Metal orthodontic brackets Patients bonded with metal brackets for orthodontic treatment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion area Time Frame: 4 months	Surface area of the lesion measured in Pixels	4 months
Mean fluorescence loss ∆F(%) Time Frame: 4 months	Mean lesion fluorescence loss reflecting mineral loss measured in percent	4 months
Maximum fluorescence loss ∆Fmax(%) Time Frame: 4 months	Deepest point of the lesion	4 months
Incidence of white spot lesions Time Frame: 4 months	The number of newly developed white spot lesions	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque measurement Time Frame: 4 months	Amount of plaque around the orthodontic fixed appliance	4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Investigators

Principal Investigator: Susan Al-Khateeb, Professor, Faculty of Dentistry/Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2021

Primary Completion (Actual)

July 7, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

February 4, 2023

First Submitted That Met QC Criteria

March 1, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

JUST20220107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Data will be available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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