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

NCT05764187 | Completed

• 1 other identifier: JUST20220107
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

White Spot Lesion of Tooth

Outcome Measures

Primary Outcomes (4)

• Lesion area

  Surface area of the lesion measured in Pixels

  4 months

• Mean fluorescence loss ∆F(%)

  Mean lesion fluorescence loss reflecting mineral loss measured in percent

  4 months

• Maximum fluorescence loss ∆Fmax(%)

  Deepest point of the lesion

  4 months

• Incidence of white spot lesions

  The number of newly developed white spot lesions

  4 months

Secondary Outcomes (1)

• Plaque measurement

  4 months

Study Arms (2)

Ceramic orthodontic brackets

EXPERIMENTAL

Patients bonded with ceramic brackets for orthodontic treatment

Other: Orthodontic fixed appliance therapy

Metal orthodontic brackets

ACTIVE COMPARATOR

Patients bonded with metal brackets for orthodontic treatment

Other: Orthodontic fixed appliance therapy

Interventions

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

Ceramic orthodontic brackets; Metal orthodontic brackets

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Subjects with poor oral hygiene
• Defective enamel
• Patients with syndromes and Oro-facial anomalies or salivary glands diseases

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Postgraduate Teaching Dental Clinics/JUST

Irbid, 22110, Jordan

Location

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Study Officials

• Susan Al-Khateeb, Professor

  Faculty of Dentistry/Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It was not possible to mask nether the participants nor the care provider
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two parallel arm randomized clinical trial

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: March 10, 2023
• Study Start: December 28, 2021
• Primary Completion: July 7, 2022
• Study Completion: December 1, 2022
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)