Orthodontic Appliance ComplicationNCT03362034
Chairside Time and Accuracy of Indirect Bonding of Orthodontic Attachments Using Double Versus Single Transfer Tray
A study testing double transfer trays and single transfer tray in people with Orthodontic Appliance Complication, run by Cairo University.
Trial summary
compare the chairside time and the accuracy of transferring attachments between single and double sheets vacuum tray techniques during indirect bonding of orthodontic attachments using superimposition on computer software Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- double transfer trays and single transfer tray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Mar 2019
- 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
- Patient with maxillary full set of teeth and undergoing fixed orthodontic treatment.
- Good oral hygiene.
- Mild to moderate crowding.
Who cannot join
- Patients with partially erupted teeth in the maxillary arch.
- Signs of caries, large restorations or abnormalities of crown morphology.
- The need of banding.
- Bad oral hygiene measures.
About this study
Official title: Chairside Time and Accuracy of Indirect Bonding of Orthodontic Attachments Using Double Versus Single Transfer Tray: A Randomized Controlled Trial
compare the chairside time and the accuracy of transferring attachments between single and double sheets vacuum tray techniques during indirect bonding of orthodontic attachments using superimposition on computer software
- Conditions
- Orthodontic Appliance Complication
- Being tested
- double transfer trays, single transfer tray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
double transfer traysDevice
double trays one soft and one hard
single transfer trayDevice
single soft tray
| Study group | Role | What they receive |
|---|---|---|
| single transfer tray | Active comparator | Not described Receives: Device: single transfer tray |
| double transfer trays | Experimental | Not described Receives: Device: double transfer trays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chairside time of brackets bonding
using Stop watch
Measured: an average of 30 minutes
Secondary outcomes (2)
Accuracy of orthodontic attachments transfer
linear (mm) scale using geomagic software
Measured: one day after bonding
Accuracy of orthodontic attachments transfer
angular (degrees) scale using geomagic software
Measured: one day after bonding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study startJan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionMar 2019 (estimated)
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.
- More trials run by Cairo 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed essam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362034
- Sponsor's protocol ID
- CEBC-CU-2017-11-14
- Status last verified
- Dec 2017
- First submitted
- 21 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chairside Time and Accuracy of Indirect Bonding of Orthodontic Attachments Using Double Versus Single Transfer Tray: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03362034
- Acronym / sponsor ID
- CEBC-CU-2017-11-14
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 5 Dec 2017 (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.
compare the chairside time and the accuracy of transferring attachments between single and double sheets vacuum tray techniques during indirect bonding of orthodontic attachments using superimposition on computer software
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single transfer tray | Active comparator | Device: single transfer tray |
| double transfer trays | Experimental | Device: double transfer trays |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with maxillary full set of teeth and undergoing fixed orthodontic treatment.
- Good oral hygiene.
- Mild to moderate crowding.
Key exclusion criteria (4 listed)
- Patients with partially erupted teeth in the maxillary arch.
- Signs of caries, large restorations or abnormalities of crown morphology.
- The need of banding.
- Bad oral hygiene measures.
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 |
|---|---|---|
| double transfer traysdouble trays one soft and one hard | Device | double transfer trays |
| single transfer traysingle soft tray | Device | single transfer tray |
Primary outcome
Chairside time of brackets bonding
Time frame: an average of 30 minutes
using Stop watch
2 secondary outcomes
Accuracy of orthodontic attachments transfer
Time frame: one day after bonding
Accuracy of orthodontic attachments transfer
Time frame: one day after bonding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing double transfer trays and single transfer tray in people with Orthodontic Appliance Complication, run by Cairo University.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Chairside time of brackets bonding (time frame: an average of 30 minutes). 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 5 Dec 2017.