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Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

Sponsor
Jordan University of Science and Technology (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05738356
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
15.7
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Adhesive bonding systems
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three parallel groupsThree parallel groups
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The investigator was capturing the images (that were analyzed to measure the outcomes), while a research assistant was saving the images of the patients with coding system
Primary Purpose:
Diagnostic
Official Title:
Comparison of Three Orthodontic Bonding Systems in White Spot Lesion Development: A Randomized Clinical Trial
Actual Study Start Date :
Dec 10, 2021
Actual Primary Completion Date :
Jun 16, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Average lesion fluorescence loss (ΔF%) [4 months]

    It reflects mineral loss from tooth surface (in percent)

  2. surface area of WSL [4 months]

    Area of mineral loss measured in pixels

  3. Incidence of WSL [4 months]

    Number of newly developed WSLs

Secondary Outcome Measures

  1. Maximum lesion fluorescence loss (ΔFMAX%) [4 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Jordan University of Science and Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Jordan University of Science and Technology
ClinicalTrials.gov Identifier:
NCT05738356
Other Study ID Numbers:
  • JUST20220118
First Posted:
Feb 22, 2023
Last Update Posted:
Feb 22, 2023
Last Verified:
Feb 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
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Jordan University of Science and Technology
Self-etch primer, one step adhesive, conventional bonding system

Study Results

No Results Posted as of Feb 22, 2023