Orthodontic AppliancesNCT04456114
Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases
A study testing Acid etched brackets and Sandblasted brackets in people with Orthodontic Appliances, run by Riphah International University at 1 site in Pakistan.
Trial summary
To describe a method of acid etching the base of a bracket, and to compare the bond failures between micro-abrasive blasted (sandblasted) brackets and acid etched brackets over an eighteen month period Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliances
- What is being tested?
- Acid etched brackets and Sandblasted brackets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2018to 31 Jan 2020
- 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
- Patients about to undergo fixed orthodontic therapy
Who cannot join
- Patients with cavities, history of fixed orthodontic therapy, recent bleaching
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases: A Scanning Electron Microscope Study and an Eighteen Month Randomized Clinical Control
To describe a method of acid etching the base of a bracket, and to compare the bond failures between micro-abrasive blasted (sandblasted) brackets and acid etched brackets over an eighteen month period
Read the detailed description
The aims of this randomized control trial are:
- To describe a method to chemically etch the bases of stainless steel orthodontic brackets.
- To observe the changes in the micro-structure of the brackets with sandblasted bases and acid-etched bases under an electron microscope.
- To compare the failure of orthodontic brackets with a chemical etched base versus a sandblasted base bonded with composite using the conventional acid etch technique, over a follow-up of 18 months
- Conditions
- Orthodontic Appliances
- Being tested
- Acid etched brackets, Sandblasted brackets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acid etched bracketsDevice
The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months
Sandblasted bracketsDevice
The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months
| Study group | Role | What they receive |
|---|---|---|
| Acid etched brackets | Experimental | Stainless steel bracket base etched with 10% Hydrofluoric acid for 1 minute Receives: Device: Acid etched brackets |
| Sandblasted brackets | Active comparator | Stainless steel bracket sandblasted base Receives: Device: Sandblasted brackets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bond Failure Rate
To compare the bond failure rates between acid etched and sandblasted brackets. Done by calculating and comparing the percentages of bracket breakages between the acid etched and sandblasted bracket quadrants.
Measured: 18 months after placement of brackets on the teeth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jun 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic AppliancesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group, split mouth, triple blinded, randomized control trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Owais Khalid Durrani, Riphah International University
- Investigators
- Owais K Durrani, FFDRCSI, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456114
- Sponsor's protocol ID
- IIDC/IRB/06/06/2020
- Status last verified
- Jul 2020
- First submitted
- 27 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases: A Scanning Electron Microscope Study and an Eighteen Month Randomized Clinical Control
- ClinicalTrials.gov ID
- NCT04456114
- Acronym / sponsor ID
- IIDC/IRB/06/06/2020
- Conditions
- Orthodontic Appliances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 2 Jul 2020 (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.
To describe a method of acid etching the base of a bracket, and to compare the bond failures between micro-abrasive blasted (sandblasted) brackets and acid etched brackets over an eighteen month period
Detailed description
The aims of this randomized control trial are:
- To describe a method to chemically etch the bases of stainless steel orthodontic brackets.
- To observe the changes in the micro-structure of the brackets with sandblasted bases and acid-etched bases under an electron microscope.
- To compare the failure of orthodontic brackets with a chemical etched base versus a sandblasted base bonded with composite using the conventional acid etch technique, over a follow-up of 18 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel-group, split mouth, triple blinded, randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Acid etched brackets | Experimental | Device: Acid etched bracketsStainless steel bracket base etched with 10% Hydrofluoric acid for 1 minute |
| Sandblasted brackets | Active comparator | Device: Sandblasted bracketsStainless steel bracket sandblasted base |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients about to undergo fixed orthodontic therapy
Key exclusion criteria (1 listed)
- Patients with cavities, history of fixed orthodontic therapy, recent bleaching
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 |
|---|---|---|
| Acid etched bracketsThe brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months | Device | Acid etched brackets |
| Sandblasted bracketsThe brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months | Device | Sandblasted brackets |
Primary outcome
Bond Failure Rate
Time frame: 18 months after placement of brackets on the teeth
To compare the bond failure rates between acid etched and sandblasted brackets. Done by calculating and comparing the percentages of bracket breakages between the acid etched and sandblasted bracket quadrants.
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 7 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Owais K Durrani, FFDRCSI principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acid etched brackets and Sandblasted brackets in people with Orthodontic Appliances, run by Riphah International University at 1 site in Pakistan.
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 1 inclusion and 1 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 7 Jul 2020. 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 Pakistan. 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?
Bond Failure Rate (time frame: 18 months after placement of brackets on the teeth). 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 7 Jul 2020.