Orthodontic Appliance ComplicationNCT05812456
Comparison Between Shear Bond Strength of Different Commercial Metal Bracket Brands: an in Vitro Study
A study testing Estimation of Shear Bond Strength in people with Orthodontic Appliance Complication and Shear Strength, run by Future University in Egypt at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication, Shear Strength
- What is being tested?
- Estimation of Shear Bond Strength
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- teeth with amelogenesis or dentinogenesis imperfecta.
- labially restored teeth.
- endodontically treated teeth.
- teeth with fluorosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Shear Bond Strength of Different Commercial Brands of Stainless Steel Orthodontic Brackets: An in Vitro Study
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.
Read the detailed 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.
- Conditions
- Orthodontic Appliance Complication, Shear Strength
- Being tested
- Estimation of Shear Bond Strength
- Keywords
- Orthodontic brackets brands, Shear bond strength, Remanent adhesive Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estimation of Shear Bond StrengthOther
Also called Evaluation of Adhesive Remnant Index
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Estimation of Shear Bond Strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 hours
Secondary outcomes (1)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Dec 2020
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Hamdy Mohamed Afifi, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812456
- Sponsor's protocol ID
- FUE.REC(29)/12/2020
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Shear Bond Strength of Different Commercial Brands of Stainless Steel Orthodontic Brackets: An in Vitro Study
- ClinicalTrials.gov ID
- NCT05812456
- Acronym / sponsor ID
- FUE.REC(29)/12/2020
- Conditions
- Orthodontic Appliance Complication, Shear Strength
- Keywords
- Orthodontic brackets brands, Shear bond strength, Remanent adhesive Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3m Metal Brackets | Active comparator | Other: Estimation of Shear Bond Strength3m 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 |
| American Orthodontics Metal Brackets | Active comparator | Other: Estimation of Shear Bond StrengthAmerican 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 |
| Fanta Metal Brackets | Experimental | Other: Estimation of Shear Bond StrengthFanta 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 |
| Matt Orthodontics Metal Brackets | Experimental | Other: Estimation of Shear Bond StrengthMatt 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- teeth with amelogenesis or dentinogenesis imperfecta.
- labially restored teeth.
- endodontically treated teeth.
- teeth with fluorosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estimation of Shear Bond StrengthAlso: Evaluation of Adhesive Remnant IndexMeasuring 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. | Other | 3m Metal Brackets, American Orthodontics Metal Brackets, Fanta Metal Brackets, Matt Orthodontics Metal Brackets |
Primary outcome
Estimation of Shear Bond Strength
Time frame: 24 hours
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).
1 secondary outcome
Evaluation of Adhesive Remanent Index
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Orthodontic Appliance Complication
Recruiting
Bacterial Diversity Study Using 16S rRNA Sequencing of Periodontal Samples From Patients With Orthodontic Retainers
Fixed Orthodontic Retainer, Orthodontic Appliances, Removable
Recruiting
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
White Spot Lesions, Orthodontic Appliance Complication
Recruiting
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
Orthodontic Appliance, Pain
Not yet recruiting
Comparison of a 3-step Bonding System (Transbond™ XT) and a 2-step System (GC Ortho Connect™) on Demineralization Around Maxillary Orthodontic Brackets
Tooth Demineralization, White Spot Lesion
Recruiting
Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances
Orthodontic Appliances, Removable, Orthodontic Appliance Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estimation of Shear Bond Strength in people with Orthodontic Appliance Complication and Shear Strength, run by Future University in Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimation of Shear Bond Strength (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.