Comparison Between Shear Bond Strength of Different Commercial Metal Bracket Brands: an in Vitro Study

Orthodontic Appliance Complication Clinical Trial

Official title:

Comparison of Shear Bond Strength of Different Commercial Brands of Stainless Steel Orthodontic Brackets: An in Vitro Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05812456
• Other study ID #: FUE.REC(29)/12/2020
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2023
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

some orthodontic brands are more expensive than others, one of the primary outcomes of this study is to know if is it worth using expensive brands? will it provide better quality treatment, in particular, bond strength? The treatment duration is long therefore it is expensive, either for the orthodontist and/or the patient.

This study will be comparing the bond strength of different commercial brands of stainless steel brackets.

Description:

There are a plethora of studies in the science of orthodontics discussing different massive advances in the orthodontic adhesion concepts that allowed orthodontists to successfully bond brackets and tubes to teeth. the bond strength between the bracket and tooth should be sufficient to withstand the forces of mastication and the aggressive conditions of the oral environment. a commonly encountered problem is the failure of the bond between the bracket and tooth during treatment.

There are a lot of orthodontic in vitro studies that discussed bond failure and strength. multiple studies have studied the bracket-enamel bond strength with different curing systems and found that there was no significant difference in terms of bond strength. Several other studies discussed the effect of different adhesive systems on the bond strength to the enamel.

There are many studies that debated the shear bond strength of different metal bracket base shapes and sizes concluding that no differences in SBS for the surface area within the range of 6.82-12.35mm2 as well as the shape of the bracket base had no effect on shear bond strength.

The effectiveness or the success of the orthodontic treatment is arbitrated by achieving better aesthetics, better function, and better judgment for the patient too.

Even if there was a plethora of studies comparing the bond strength of different bracket shapes and sizes and also between metal and ceramic brackets, however, none have considered comparing shear bond strength of different bracket brands to enamel, Considering its cost and repeated failure which has its implication on both patient and orthodontist.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• sound extracted upper and/or lower permanent premolars.

• Intact buccal enamel surface with n erosion and cracks.

• the teeth must be free from caries, restoration, white spot lesions, or any sign of decalcification.

• No pretreatment with any chemical agents such as hydrogen peroxide or formalin.

Exclusion Criteria:

• teeth with amelogenesis or dentinogenesis imperfecta.

• labially restored teeth.

• endodontically treated teeth.

• teeth with fluorosis.

Related Conditions & MeSH terms

• Orthodontic Appliance Complication
• Shear Strength

Intervention

Other:
• Estimation of Shear Bond Strength
Measuring shear bond strength between the different bracket brands and the enamel will be estimated by aiming the edge of the blade of the universal testing machine at bracket-enamel interface. The force required to debond each bracket will be registered in Newtons (N), and converted to Megapascals by dividing the force registered in newtons on each bracket base area (mm2). After bond failure, the brackets and the enamel surfaces will be examined and assessed for the amount of adhesive remaining on the bracket bases by using digital microscope at 35x magnification. this will identify the site of bond failure.

Locations

Country	Name	City	State
Egypt	Future Unversity in Egypt	New Cairo	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of Shear Bond Strength	Measuring shear bond strength between the different bracket brands and the enamel will be estimated by aiming the edge of the blade of the universal testing machine at bracket-enamel interface. The force required to debond each bracket will be registered in Newtons (N), and converted to Megapascals by dividing the force registered in newtons on each bracket base area (mm2).	24 hours
Secondary	Evaluation of Adhesive Remanent Index	ARI scale is used to asses site of bond failure After bond failure, the brackets and the enamel surfaces will be examined and assessed for the amount of adhesive remaining on the bracket bases by using digital microscope at 35x magnification.	24 hours