Clinical trial NCT05738356: Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems
Official title: Comparison of Three Orthodontic Bonding Systems in White Spot Lesion Development: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesion
Keywords: Self-etch primer, one step adhesive
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 75
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three parallel groups
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Average lesion fluorescence loss (ΔF%)
timeFrame: 4 months
measure: surface area of WSL
timeFrame: 4 months
measure: Incidence of WSL
timeFrame: 4 months
Secondary outcomes:
measure: Maximum lesion fluorescence loss (ΔFMAX%)
timeFrame: 4 months
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Postgraduate Dental Teaching Clinics/JUST
Study officials:
affiliation: Faculty of Dentistry/Jordan University of Science and Technology
name: Susan Al-Khateeb, PhD
role: PRINCIPAL_INVESTIGATOR
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