Orthodontic Indirect BondingNCT03363607
Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding
A study testing Digital indirect bonding, Conventional indirect bonding and Intraoral scanning in people with Orthodontic Indirect Bonding, run by Cairo University.
Trial summary
The study evaluates the accuracy of indirect bonding using 3D printed transfer tray versus thermoformed transfer tray. Half of the brackets will be bonded indirectly using the 3D printed transfer tray and the other half will be bonded indirectly using the thermoformed transfer tray. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Indirect Bonding
- What is being tested?
- Digital indirect bonding, Conventional indirect bonding and Intraoral scanning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients seeking orthodontic treatment with fixed orthodontic appliance.
- Patients with full set of permanent teeth
- Good oral hygiene and periodontal condition.
Who cannot join
- Patients suffering from any periodontal disease.
- Patients with poor oral hygiene
- Enamel hypoplasia and hypocalcification
- Deep carious lesions / large restorations
About this study
Official title: Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding: A Randomized Clinical Trial
The study evaluates the accuracy of indirect bonding using 3D printed transfer tray versus thermoformed transfer tray. Half of the brackets will be bonded indirectly using the 3D printed transfer tray and the other half will be bonded indirectly using the thermoformed transfer tray.
- Conditions
- Orthodontic Indirect Bonding
- Being tested
- Digital indirect bonding, Conventional indirect bonding, Intraoral scanning, Superimposition and evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital indirect bondingProcedure or surgery
Indirect bonding of orthodontic attachments using digital 3D printed transfer tray
Conventional indirect bondingProcedure or surgery
Indirect bonding of orthodontic attachments using thermoformed transfer tray
Intraoral scanningProcedure or surgery
Intraoral Scanning of the bonded brackets
Superimposition and evaluationProcedure or surgery
superimposition of the brackets' positions before and after bonding and evaluation of the transfer accuracy
| Study group | Role | What they receive |
|---|---|---|
| 3D printed transfer tray group | Experimental | Indirect bonding using digital 3D printed transfer tray Receives: Procedure: Digital indirect bonding; Procedure: Intraoral scanning; Procedure: Superimposition and evaluation |
| Thermoformed transfer tray group | Active comparator | Indirect bonding using Thermoformed transfer tray Receives: Procedure: Conventional indirect bonding; Procedure: Intraoral scanning; Procedure: Superimposition and evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear and angular Positioning of the brackets
To evaluate the transfer accuracy of the brackets by the two transfer trays by measuring the linear and angular differences in the brackets' positions before and after bonding.
Measured: Immediately after bonding
Secondary outcomes (2)
Bonding failure of the brackets.
Evaluation of the bond failure by counting the number of detached brackets immediately and over a three months follow up period.
Measured: three months
Chair side time
To evaluate the chair side time of indirect bonding in each technique
Measured: during the bonding procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (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 Indirect BondingStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Abdelaziz, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363607
- Sponsor's protocol ID
- CEBC-CU-2017-11-28
- Status last verified
- Nov 2017
- First submitted
- 26 Nov 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Digital 3D Printed Transfer Tray Versus Thermoformed Transfer Tray for Indirect Bonding: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03363607
- Acronym / sponsor ID
- CEBC-CU-2017-11-28
- Conditions
- Orthodontic Indirect Bonding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 6 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.
The study evaluates the accuracy of indirect bonding using 3D printed transfer tray versus thermoformed transfer tray. Half of the brackets will be bonded indirectly using the 3D printed transfer tray and the other half will be bonded indirectly using the thermoformed transfer tray.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printed transfer tray group | Experimental | Procedure: Digital indirect bonding, Procedure: Intraoral scanning, Procedure: Superimposition and evaluationIndirect bonding using digital 3D printed transfer tray |
| Thermoformed transfer tray group | Active comparator | Procedure: Conventional indirect bonding, Procedure: Intraoral scanning, Procedure: Superimposition and evaluationIndirect bonding using Thermoformed transfer tray |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients seeking orthodontic treatment with fixed orthodontic appliance.
- Patients with full set of permanent teeth
- Good oral hygiene and periodontal condition.
Key exclusion criteria (4 listed)
- Patients suffering from any periodontal disease.
- Patients with poor oral hygiene
- Enamel hypoplasia and hypocalcification
- Deep carious lesions / large restorations
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 |
|---|---|---|
| Digital indirect bondingIndirect bonding of orthodontic attachments using digital 3D printed transfer tray | Procedure or surgery | 3D printed transfer tray group |
| Conventional indirect bondingIndirect bonding of orthodontic attachments using thermoformed transfer tray | Procedure or surgery | Thermoformed transfer tray group |
| Intraoral scanningIntraoral Scanning of the bonded brackets | Procedure or surgery | 3D printed transfer tray group, Thermoformed transfer tray group |
| Superimposition and evaluationsuperimposition of the brackets' positions before and after bonding and evaluation of the transfer accuracy | Procedure or surgery | 3D printed transfer tray group, Thermoformed transfer tray group |
Primary outcome
Linear and angular Positioning of the brackets
Time frame: Immediately after bonding
To evaluate the transfer accuracy of the brackets by the two transfer trays by measuring the linear and angular differences in the brackets' positions before and after bonding.
2 secondary outcomes
Bonding failure of the brackets.
Time frame: three months
Chair side time
Time frame: during the bonding procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
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Orthodontic Treatment
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 Digital indirect bonding, Conventional indirect bonding and Intraoral scanning in people with Orthodontic Indirect Bonding, 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 6 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?
Linear and angular Positioning of the brackets (time frame: Immediately after bonding). 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 6 Dec 2017.