Orthodontic Appliance ComplicationNCT03365232
Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding
A study testing non custom base attachment and custom base attachment in people with Orthodontic Appliance Complication, run by Cairo University.
Trial summary
compare the chair side time, clinical orthodontic attachment bond failure and accuracy of transfer between non custom attachment base and custom attachment base indirect techniques. 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?
- non custom base attachment and custom base attachment
- 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
- Patients should have
- Maxillary sound teeth and undergoing fixed orthodontic treatment.
- Space problems ranging from spacing to mild crowding.
- Good oral hygiene.
Who cannot join
- Patients with partially erupted teeth in the maxillary arch .
- Signs of caries, large restorations fluorosis, hypoplasia or abnormalities of crown morphology.
- The need of banding.
- Bad oral hygiene measures.
About this study
Official title: Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding: A Randomized Clinical Trial
compare the chair side time, clinical orthodontic attachment bond failure and accuracy of transfer between non custom attachment base and custom attachment base indirect techniques.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- non custom base attachment, custom base attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non custom base attachmentDevice
non custom base attachment
custom base attachmentDevice
custom base attachment
| Study group | Role | What they receive |
|---|---|---|
| non custom base attachment | Experimental | Not described Receives: Device: non custom base attachment |
| custom base attachment | Active comparator | Not described Receives: Device: custom base attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
chair side time
using stopwatch
Measured: an average of 30 minutes
Secondary outcomes (1)
immediate bond failure
number of debonded attachments using hand instrument pressure
Measured: immediately after bonding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 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 Saied Mahmoud Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365232
- Sponsor's protocol ID
- CEBC-CU-2017-11-13
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2017
- Last updated
- 7 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 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03365232
- Acronym / sponsor ID
- CEBC-CU-2017-11-13
- 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
- 7 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 chair side time, clinical orthodontic attachment bond failure and accuracy of transfer between non custom attachment base and custom attachment base indirect techniques.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non custom base attachment | Experimental | Device: non custom base attachment |
| custom base attachment | Active comparator | Device: custom base attachment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients should have
- Maxillary sound teeth and undergoing fixed orthodontic treatment.
- Space problems ranging from spacing to mild crowding.
- Good oral hygiene.
Key exclusion criteria (4 listed)
- Patients with partially erupted teeth in the maxillary arch .
- Signs of caries, large restorations fluorosis, hypoplasia 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 |
|---|---|---|
| non custom base attachmentnon custom base attachment | Device | non custom base attachment |
| custom base attachmentcustom base attachment | Device | custom base attachment |
Primary outcome
chair side time
Time frame: an average of 30 minutes
using stopwatch
1 secondary outcome
immediate bond failure
Time frame: immediately after bonding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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 non custom base attachment and custom base attachment 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 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: status not confirmed, as of the sponsor's last update on 7 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?
chair side time (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 7 Dec 2017.