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OpenTrials
Completed

NCT Number: NCT05738356

Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

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

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Key information

Conditions

White Spot Lesion

Age range

17 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Postgraduate Dental Teaching Clinics/JUST

Irbid, 22110, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adhesive bonding systems

Combination Product

Three different adhesive bonding systems were used; one system per group

Primary outcomes

  1. Average lesion fluorescence loss (ΔF%)

    Time frame: 4 months

    It reflects mineral loss from tooth surface (in percent)

  2. surface area of WSL

    Time frame: 4 months

    Area of mineral loss measured in pixels

  3. Incidence of WSL

    Time frame: 4 months

    Number of newly developed WSLs

Secondary outcomes

  1. Maximum lesion fluorescence loss (ΔFMAX%)

    Time frame: 4 months

    It reflects the deepest area of the WSL (in percent)

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 22, 2023
Registry last updated
May 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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