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

J

Jordan University of Science and Technology

Status

Completed

Conditions

White Spot Lesion of Tooth

Treatments

Other: Orthodontic fixed appliance therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05764187
JUST20220107

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

51 participants in 2 patient groups

Ceramic orthodontic brackets
Experimental group
Description:
Patients bonded with ceramic brackets for orthodontic treatment
Treatment:
Other: Orthodontic fixed appliance therapy
Metal orthodontic brackets
Active Comparator group
Description:
Patients bonded with metal brackets for orthodontic treatment
Treatment:
Other: Orthodontic fixed appliance therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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