Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding TrayNCT03564717
Evaluation of Segmented Versus Full Arch Three Dimensionally Printed Transfer Tray for Orthodontic Indirect Bonding
A study testing Segmented three dimensionally printed transfer tray in people with Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray and Accuracy of Bracket Transfer and Bond Failure Rate of Full Arch and Segmented Digitally Printed Trays, run by Cairo University.
Trial summary
This study is conducted to overcome the problems of conventional indirect bonding technique, through investigating accuracy of two novel three dimensionally digitally printed indirect bonding transfer trays (full arch \& segmented) in terms of accuracy of transferring brackets, rate of immediate bond failure and chair… Read more about this study
- Who is it for?
- Ages 16 to 38 years
- Conditions the study is for
- Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray, Accuracy of Bracket Transfer and Bond Failure Rate of Full Arch and Segmented Digitally Printed Trays
- What is being tested?
- Segmented three dimensionally printed transfer tray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 30 Dec 2018
- 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 16 to 38 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients seeking fixed orthodontic treatment with full set of permanent teeth including second molars.
- No sex predilection.
- Mild to moderate crowding cases (4-6 mm).
Who cannot join
- Severely rotated teeth
- Enamel hypoplasia or hypocalcification.
- Systemic disease that contraindicates orthodontic treatment.
- Presence of deep carious lesions or large restorations.
- No or poor patient's compliance \& bad oral hygiene.
- Psychological problems.
About this study
Official title: Evaluation of Segmented Versus Full Arch Three Dimensionally Printed Transfer Tray for Orthodontic Indirect Bonding: Randomized Controlled Trial
This study is conducted to overcome the problems of conventional indirect bonding technique, through investigating accuracy of two novel three dimensionally digitally printed indirect bonding transfer trays (full arch \& segmented) in terms of accuracy of transferring brackets, rate of immediate bond failure and chair side time.
Read the detailed description
Fourteen patients (7 in each group) with mild to moderate crowding, requiring orthodontic treatment with full set of permanent teeth including second molars, will be selected for this study. A total of 196 brackets will be used (98 Full Arch Tray and 98 Segment Arch Tray). The same bracket type and bonding material will used in both groups. The accuracy of bracket transfer will be measured by 3 Shape Ortho planner software (Bracket Placement Module), rate of bond failure by counting number of debonded brackets upon tray removal \& chair side time by using digital watch.
- Conditions
- Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray, Accuracy of Bracket Transfer and Bond Failure Rate of Full Arch and Segmented Digitally Printed Trays
- Being tested
- Segmented three dimensionally printed transfer tray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmented three dimensionally printed transfer trayOther
Segmented indirect bonding transfer tray
| Study group | Role | What they receive |
|---|---|---|
| Segmented Three dimensionally printed transfer tray | Experimental | Not described Receives: Other: Segmented three dimensionally printed transfer tray |
| Full arch three dimensionally printed transfer tray | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of 3D printed full arch &segmented transfer tray.
Using Digital Measurements on 3shape software in mm- degrees
Measured: immediate
Secondary outcomes (2)
Chairside Time
Digital stopwatch in seconds
Measured: immediate
Immediate Bond Failure
Counting number of brackets or tubes failed immediately after bonding
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion30 Nov 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding TrayStudies 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Alaa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564717
- Sponsor's protocol ID
- CEBD-CU-2018-04-17
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2018
- Last updated
- 21 Jun 2018
- 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 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Segmented Versus Full Arch Three Dimensionally Printed Transfer Tray for Orthodontic Indirect Bonding: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03564717
- Acronym / sponsor ID
- CEBD-CU-2018-04-17
- Conditions
- Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray, Accuracy of Bracket Transfer and Bond Failure Rate of Full Arch and Segmented Digitally Printed Trays
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 21 Jun 2018 (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.
This study is conducted to overcome the problems of conventional indirect bonding technique, through investigating accuracy of two novel three dimensionally digitally printed indirect bonding transfer trays (full arch \& segmented) in terms of accuracy of transferring brackets, rate of immediate bond failure and chair side time.
Detailed description
Fourteen patients (7 in each group) with mild to moderate crowding, requiring orthodontic treatment with full set of permanent teeth including second molars, will be selected for this study. A total of 196 brackets will be used (98 Full Arch Tray and 98 Segment Arch Tray). The same bracket type and bonding material will used in both groups. The accuracy of bracket transfer will be measured by 3 Shape Ortho planner software (Bracket Placement Module), rate of bond failure by counting number of debonded brackets upon tray removal \& chair side time by using digital watch.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Segmented Three dimensionally printed transfer tray | Experimental | Other: Segmented three dimensionally printed transfer tray |
| Full arch three dimensionally printed transfer tray | No intervention | – |
Who may qualify
- Ages
- 16 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients seeking fixed orthodontic treatment with full set of permanent teeth including second molars.
- No sex predilection.
- Mild to moderate crowding cases (4-6 mm).
Key exclusion criteria (6 listed)
- Severely rotated teeth
- Enamel hypoplasia or hypocalcification.
- Systemic disease that contraindicates orthodontic treatment.
- Presence of deep carious lesions or large restorations.
- No or poor patient's compliance \& bad oral hygiene.
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 |
|---|---|---|
| Segmented three dimensionally printed transfer traySegmented indirect bonding transfer tray | Other | Segmented Three dimensionally printed transfer tray |
Primary outcome
Accuracy of 3D printed full arch &segmented transfer tray.
Time frame: immediate
Using Digital Measurements on 3shape software in mm- degrees
2 secondary outcomes
Chairside Time
Time frame: immediate
Immediate Bond Failure
Time frame: immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Individual participant dataSharing planned: Undecided
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 Segmented three dimensionally printed transfer tray in people with Inaccurate Transfer and Bond Failure of Conventional Indirect Bonding Tray and Accuracy of Bracket Transfer and Bond Failure Rate of Full Arch and Segmented Digitally Printed Trays, 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 6 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 21 Jun 2018. 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?
Accuracy of 3D printed full arch &segmented transfer tray. (time frame: immediate). 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 21 Jun 2018.