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

NCT ID: NCT05812456

Last Updated: 2023-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Orthodontic Appliance Complication Shear Strength

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
this is a double-blinded study (investigator-outcome assessor) this is a double-blinded study, for both the investigator and outcome assessor, as the investigator will be responsible for collecting the sample and preparing the sample for the experiment.

The outcome assessors will be blinded during the intervention application. as he/she will be responsible for analyzing the results of each group in the experiment.

Study Groups

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3m Metal Brackets

3m Unitek Gemini Roth Stainless-Steel Brackets. it is passive Stainless-Steel components used in fixed Orthodontics appliance to help in solving malocclusions by bonding it to teeth's enamel. it acts as a means to transfers forces applied by activated archwires inserted in bracket slots to try to correct and improve the patients malocclusion problems.

There are different sizes of Stainless-Steel bracket slots, There are 0.018 slot and 0.022 slot.

Brackets are made of many different materials such as Stainless-Steel, ceramics, plastic or 3d printed. The most used type is metal brackets.

Brackets come with built in prescriptions of torque and tip, there are two type of prescriptions: Roth and MBT

Group Type ACTIVE_COMPARATOR

Estimation of Shear Bond Strength

Intervention Type OTHER

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.

American Orthodontics Metal Brackets

American Orthodontics Mini Masters 0.022 Roth Stainless-Steel Brackets. it is passive Stainless-Steel components used in fixed Orthodontics appliance to help in solving malocclusions by bonding it to teeth's enamel. it acts as a means to transfers forces applied by activated archwires inserted in bracket slots to try to correct and improve the patients malocclusion problems.

There are different sizes of Stainless-Steel bracket slots, There are .18 slot and .22 slot.

Brackets are made of many different materials such as Stainless-Steel, ceramics, plastic or 3d printed. The most used type is metal brackets.

Brackets come with built in prescriptions of torque and tip, there are two type of prescriptions: Roth and MBT

Group Type ACTIVE_COMPARATOR

Estimation of Shear Bond Strength

Intervention Type OTHER

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.

Fanta Metal Brackets

Fanta Firmax 0.022 Roth Stainless-Steel Brackets. Fanta is a Chinese Orthodontic bracket brand that started to spread.

it is passive Stainless-Steel components used in fixed Orthodontics appliance to help in solving malocclusions by bonding it to teeth's enamel. it acts as a means to transfers forces applied by activated archwires inserted in bracket slots to try to correct and improve the patients malocclusion problems.

There are different sizes of Stainless-Steel bracket slots, There are 0.018 slot and 0.022 slot.

Brackets are made of many different materials such as Stainless-Steel, ceramics, plastic or 3d printed. The most used type is metal brackets.

Brackets come with built in prescriptions of torque and tip, there are two type of prescriptions: Roth and MBT

Group Type EXPERIMENTAL

Estimation of Shear Bond Strength

Intervention Type OTHER

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.

Matt Orthodontics Metal Brackets

Matt Orthodontics Pierre 0.022 Roth Metal Brackets. Matt is a Chinese Orthodontic bracket brand that started to spread.

it is passive Stainless-Steel components used in fixed Orthodontics appliance to help in solving malocclusions by bonding it to teeth's enamel. it acts as a means to transfers forces applied by activated archwires inserted in bracket slots to try to correct and improve the patients malocclusion problems.

There are different sizes of Stainless-Steel bracket slots, There are 0.018 slot and 0.022 slot.

Brackets are made of many different materials such as Stainless-Steel, ceramics, plastic or 3d printed. The most used type is metal brackets.

Brackets come with built in prescriptions of torque and tip, there are two type of prescriptions: Roth and MBT

Group Type EXPERIMENTAL

Estimation of Shear Bond Strength

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Evaluation of Adhesive Remnant Index

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Future University in Egypt

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Hamdy Mohamed Afifi

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Future Unversity in Egypt

New Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FUE.REC(29)/12/2020

Identifier Type: -

Identifier Source: org_study_id

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