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Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05738356
Enrollment
75
Registered
2023-02-22
Start date
2021-12-10
Completion date
2023-07-01
Last updated
2024-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Spot Lesion

Keywords

Self-etch primer, one step adhesive

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.

Interventions

COMBINATION_PRODUCTAdhesive bonding systems

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

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, 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

Intervention model description

Three parallel groups

Eligibility

Sex/Gender
ALL
Age
17 Years to 25 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Average lesion fluorescence loss (ΔF%)4 monthsIt reflects mineral loss from tooth surface (in percent)
surface area of WSL4 monthsArea of mineral loss measured in pixels
Incidence of WSL4 monthsNumber of newly developed WSLs

Secondary

MeasureTime frameDescription
Maximum lesion fluorescence loss (ΔFMAX%)4 monthsIt reflects the deepest area of the WSL (in percent)

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026