Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

NCT05738356 | Completed

• 1 other identifier: JUST20220118
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Conditions

White Spot Lesion

Keywords

Self-etch primer, one step adhesive

Outcome Measures

Primary Outcomes (3)

• Average lesion fluorescence loss (ΔF%)

  It reflects mineral loss from tooth surface (in percent)

  4 months

• surface area of WSL

  Area of mineral loss measured in pixels

  4 months

• Incidence of WSL

  Number of newly developed WSLs

  4 months

Secondary Outcomes (1)

• Maximum lesion fluorescence loss (ΔFMAX%)

  4 months

Study Arms (3)

Three-step adhesive

ACTIVE COMPARATOR

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

Self-etch primer adhesive

EXPERIMENTAL

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

One-step adhesive system

EXPERIMENTAL

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

Interventions

Adhesive bonding systems COMBINATION_PRODUCT

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

One-step adhesive system; Self-etch primer adhesive; Three-step adhesive

Eligibility Criteria

• Age: 17 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Postgraduate Dental Teaching Clinics/JUST

Irbid, 22110, Jordan

Location

Related Publications (30)

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Related Links

• Randomization App

Study Officials

• Susan Al-Khateeb, PhD

  Faculty of Dentistry/Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three parallel groups

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 22, 2023
• Study Start: December 10, 2021
• Primary Completion: June 16, 2022
• Study Completion: July 1, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)