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

NCT ID: NCT05764187

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-28

Study Completion Date

2022-12-01

Brief Summary

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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

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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

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White Spot Lesion of Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two parallel arm randomized clinical trial
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
It was not possible to mask nether the participants nor the care provider

Study Groups

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Ceramic orthodontic brackets

Patients bonded with ceramic brackets for orthodontic treatment

Group Type EXPERIMENTAL

Orthodontic fixed appliance therapy

Intervention Type 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

Metal orthodontic brackets

Patients bonded with metal brackets for orthodontic treatment

Group Type ACTIVE_COMPARATOR

Orthodontic fixed appliance therapy

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jordan University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Al-Khateeb, Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry/Jordan University of Science and Technology

Locations

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Postgraduate Teaching Dental Clinics/JUST

Irbid, , Jordan

Site Status

Countries

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Jordan

References

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Other Identifiers

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JUST20220107

Identifier Type: -

Identifier Source: org_study_id

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