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

NCT05812456 | Completed

• 1 other identifier: FUE.REC(29)/12/2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Orthodontic Appliance Complication; Shear Strength

Keywords

Orthodontic brackets brands; Shear bond strength; Remanent adhesive Index

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of Adhesive Remanent Index

  24 hours

Study Arms (4)

3m Metal Brackets

ACTIVE COMPARATOR

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

Other: Estimation of Shear Bond Strength

American Orthodontics Metal Brackets

ACTIVE COMPARATOR

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

Other: Estimation of Shear Bond Strength

Fanta Metal Brackets

EXPERIMENTAL

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

Other: Estimation of Shear Bond Strength

Matt Orthodontics Metal Brackets

EXPERIMENTAL

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

Other: Estimation of Shear Bond Strength

Interventions

Estimation of Shear Bond Strength 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.

Also known as: Evaluation of Adhesive Remnant Index

3m Metal Brackets; American Orthodontics Metal Brackets; Fanta Metal Brackets; Matt Orthodontics Metal Brackets

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• teeth with amelogenesis or dentinogenesis imperfecta.
• labially restored teeth.
• endodontically treated teeth.
• teeth with fluorosis.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future Unversity in Egypt

New Cairo, Cairo Governorate, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: April 13, 2023
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

EG (1)