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Clinical Trials/NCT05738356
NCT05738356
Completed
Not Applicable

Comparison of Three Orthodontic Bonding Systems in White Spot Lesion Development: A Randomized Clinical Trial

Jordan University of Science and Technology1 site in 1 country75 target enrollmentDecember 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
White Spot Lesion
Sponsor
Jordan University of Science and Technology
Enrollment
75
Locations
1
Primary Endpoint
Average lesion fluorescence loss (ΔF%)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The gaol of this randomized clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of white spot lesions (WSLs) during fixed orthodontic therapy in comparison with the conventional 3 step bonding system.

All participants will be bonded with similar fixed orthodontic appliances using each type of adhesives for the assigned group. WSLs will be monitored during the orthodontic treatment

Detailed Description

Objectives: The objective of this clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of WSLs during fixed orthodontic therapy in comparison with the conventional 3 step bonding system. Materials and Methods: Seventy five patients were randomly allocated into 3 groups (Group 1, conventional bonding system, n=25; Group 2, self-etch primer n=25; Group 3, primer mixed with the adhesive composite n=25). Quantitative light-induced fluorescence (QLF) was used to quantify WSL parameters. Images were captured and then analyzed before treatment; 2 months and 4 months after bond-up. Lesion area (Pixels), mean fluorescence loss (∆F) and the number of newly developed WSLs were compared within and between the 3 groups. The significance level was set at P ≤ 0.05.

Registry
clinicaltrials.gov
Start Date
December 10, 2021
End Date
July 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Healthy patients from both sexes aged 17 - 25 years
  • Mild-to-moderate crowding (≤5 mm)
  • Optimum oral hygiene
  • Maximum of 3 restored teeth
  • Absence of defective enamel formation in the form of hypocalcification or hypoplasia
  • No salivary gland diseases.

Exclusion Criteria

  • Patients with poor oral hygiene
  • Heavily restored teeth
  • Sever crowding
  • Presence of systemic disease that may affect salivary glands or the ability to brush their teeth properly.

Outcomes

Primary Outcomes

Average lesion fluorescence loss (ΔF%)

Time Frame: 4 months

It reflects mineral loss from tooth surface (in percent)

surface area of WSL

Time Frame: 4 months

Area of mineral loss measured in pixels

Incidence of WSL

Time Frame: 4 months

Number of newly developed WSLs

Secondary Outcomes

  • Maximum lesion fluorescence loss (ΔFMAX%)(4 months)

Study Sites (1)

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