Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

Not Applicable

Completed

• Conditions: White Spot Lesion
• Interventions: Combination Product: Adhesive bonding systems

• Registration Number: NCT05738356
• Lead Sponsor: Jordan University of Science and Technology

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.

Study Timeline

• Study Start: 2021-12-10
• Primary Completion: 2022-06-16
• Study First Submitted: 2023-02-04
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-22
• Study Completion: 2023-07-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Three-step adhesive	Adhesive bonding systems	The orthodontic appliances were bonded to the patients teeth using conventional 3 step adhesive (3M™ Transbond™ XT, 3M Unitek, United States)
Self-etch primer adhesive	Adhesive bonding systems	The orthodontic appliances were bonded to the patients teeth using self-etch primer (3M™ Transbond™ Plus, 3M Unitek, United States).
One-step adhesive system	Adhesive bonding systems	The orthodontic appliances were bonded to the patients teeth using one-step adhesive system (GC Ortho Connect™, GC Orthodontics, Germany)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximum lesion fluorescence loss (ΔFMAX%)	4 months	It reflects the deepest area of the WSL (in percent)

Trial Locations

Locations (1)

Postgraduate Dental Teaching Clinics/JUST; 🇯🇴 Irbid, Jordan