Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

Jordan University of Science and Technology

Status: Completed

Conditions: White Spot Lesion

Treatments: Combination Product: Adhesive bonding systems

Study type: Interventional

Funder types: Other

Identifiers

NCT05738356

JUST20220118

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 17 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

Three-step adhesive

Active Comparator group

Description:

The orthodontic appliances were bonded to the patients teeth using conventional 3 step adhesive (3M™ Transbond™ XT, 3M Unitek, United States)

Treatment:

Combination Product: Adhesive bonding systems

Self-etch primer adhesive

Experimental group

Description:

The orthodontic appliances were bonded to the patients teeth using self-etch primer (3M™ Transbond™ Plus, 3M Unitek, United States).

Treatment:

Combination Product: Adhesive bonding systems

One-step adhesive system

Experimental group

Description:

The orthodontic appliances were bonded to the patients teeth using one-step adhesive system (GC Ortho Connect™, GC Orthodontics, Germany)

Treatment:

Combination Product: Adhesive bonding systems