Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

May 1, 2024 updated by: Jordan University of Science and Technology

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

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

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Irbid, Jordan, 22110
        • Postgraduate Dental Teaching Clinics/JUST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Three-step adhesive
The orthodontic appliances were bonded to the patients teeth using conventional 3 step adhesive (3M™ Transbond™ XT, 3M Unitek, United States)
Combination product: Adhesive bonding systems
Three different adhesive bonding systems were used; one system per group
Experimental: Self-etch primer adhesive
The orthodontic appliances were bonded to the patients teeth using self-etch primer (3M™ Transbond™ Plus, 3M Unitek, United States).
Combination product: Adhesive bonding systems
Three different adhesive bonding systems were used; one system per group
Experimental: One-step adhesive system
The orthodontic appliances were bonded to the patients teeth using one-step adhesive system (GC Ortho Connect™, GC Orthodontics, Germany)
Combination product: Adhesive bonding systems
Three different adhesive bonding systems were used; one system per group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average lesion fluorescence loss (ΔF%)
Time Frame: 4 months
It reflects mineral loss from tooth surface (in percent)
4 months
surface area of WSL
Time Frame: 4 months
Area of mineral loss measured in pixels
4 months
Incidence of WSL
Time Frame: 4 months
Number of newly developed WSLs
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum lesion fluorescence loss (ΔFMAX%)
Time Frame: 4 months
It reflects the deepest area of the WSL (in percent)
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan University of Science and Technology

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2021

Primary Completion (Actual)

June 16, 2022

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

February 4, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JUST20220118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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