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

Sponsor
Jordan University of Science and Technology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05764187
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
14.1
Anticipated Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Orthodontic fixed appliance therapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two parallel arm randomized clinical trialTwo parallel arm randomized clinical trial
Masking:
Single (Outcomes Assessor)
Masking Description:
It was not possible to mask nether the participants nor the care provider
Primary Purpose:
Diagnostic
Official Title:
Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets Evaluated With Quantitative Light-induced Fluorescence: A Randomized Clinical Trial
Actual Study Start Date :
Dec 28, 2021
Actual Primary Completion Date :
Jul 7, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Lesion area [4 months]

    Surface area of the lesion measured in Pixels

  2. Mean fluorescence loss ∆F(%) [4 months]

    Mean lesion fluorescence loss reflecting mineral loss measured in percent

  3. Maximum fluorescence loss ∆Fmax(%) [4 months]

    Deepest point of the lesion

  4. Incidence of white spot lesions [4 months]

    The number of newly developed white spot lesions

Secondary Outcome Measures

  1. Plaque measurement [4 months]

    Amount of plaque around the orthodontic fixed appliance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Postgraduate Teaching Dental Clinics/JUST Irbid Jordan 22110

Sponsors and Collaborators

  • Jordan University of Science and Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jordan University of Science and Technology
ClinicalTrials.gov Identifier:
NCT05764187
Other Study ID Numbers:
  • JUST20220107
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 10, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 10, 2023