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

Not Applicable

Active, not recruiting

• Conditions: White Spot Lesion of Tooth
• Interventions: Other: Orthodontic fixed appliance therapy

• Registration Number: NCT05764187
• Lead Sponsor: Jordan University of Science and Technology

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.

Study Timeline

• Study Start: 2021-12-28
• Primary Completion: 2022-07-07
• Study First Submitted: 2023-02-04
• Status Verified: 2023-03
• Study Completion: 2023-03
• Study First Submitted QC: 2023-03-01
• Last Update Submitted: 2023-03-01
• Study First Posted: 2023-03-10
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metal orthodontic brackets	Orthodontic fixed appliance therapy	Patients bonded with metal brackets for orthodontic treatment
Ceramic orthodontic brackets	Orthodontic fixed appliance therapy	Patients bonded with ceramic brackets for orthodontic treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plaque measurement	4 months	Amount of plaque around the orthodontic fixed appliance

Trial Locations

Locations (1)

Postgraduate Teaching Dental Clinics/JUST; 🇯🇴 Irbid, Jordan