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

White Spot Lesion of Tooth Clinical Trial

Official title:

Incidence of White Spot Lesions Around Ceramic Brackets Compared With Metal Brackets Evaluated With Quantitative Light-induced Fluorescence: A Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05764187
• Other study ID #: JUST20220107
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 28, 2021
• Est. completion date: March 2023

Study information

• Verified date: March 2023
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: March 2023
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• White Spot Lesion of Tooth

Intervention

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

Locations

Country	Name	City	State
Jordan	Postgraduate Teaching Dental Clinics/JUST	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion area	Surface area of the lesion measured in Pixels	4 months
Primary	Mean fluorescence loss ?F(%)	Mean lesion fluorescence loss reflecting mineral loss measured in percent	4 months
Primary	Maximum fluorescence loss ?Fmax(%)	Deepest point of the lesion	4 months
Primary	Incidence of white spot lesions	The number of newly developed white spot lesions	4 months
Secondary	Plaque measurement	Amount of plaque around the orthodontic fixed appliance	4 months