Evaluation of White Spot Lesion Development Using 3 Orthodontic Adhesive Systems

White Spot Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05738356
• Other study ID #: JUST20220118
• Status: Completed
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: May 2024
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: July 1, 2023
• Est. primary completion date: June 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• White Spot Lesion

Intervention

Combination Product:
• Adhesive bonding systems
Three different adhesive bonding systems were used; one system per group

Locations

Country	Name	City	State
Jordan	Postgraduate Dental Teaching Clinics/JUST	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (30)

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Bishara SE, Ajlouni R, Laffoon JF, Warren JJ. Comparison of shear bond strength of two self-etch primer/adhesive systems. Angle Orthod. 2006 Jan;76(1):123-6. doi: 10.1043/0003-3219(2006)076[0123:COSBSO]2.0.CO;2. — View Citation

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average lesion fluorescence loss (?F%)	It reflects mineral loss from tooth surface (in percent)	4 months
Primary	surface area of WSL	Area of mineral loss measured in pixels	4 months
Primary	Incidence of WSL	Number of newly developed WSLs	4 months
Secondary	Maximum lesion fluorescence loss (?FMAX%)	It reflects the deepest area of the WSL (in percent)	4 months

External Links

•   Randomization App