Orthodontic Bracket PlacementNCT07503626
Optimization of Orthodontic Bracket Placement by Using Two Different Protocols of Digitally Aided Bonding
A study testing 3D printed indirect bonding trays and 3D printed guiding direct bonding trays in people with Orthodontic Bracket Placement, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the accuracy of orthodontic bracket positioning using two different protocols of digitally aided bonding. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Orthodontic Bracket Placement
- What is being tested?
- 3D printed indirect bonding trays and 3D printed guiding direct bonding trays
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Mar 2026to 30 Apr 2026
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with permanent dentition starting orthodontic treatment requiring vestibular fixed orthodontic appliance according to treatment needs.
- Fully erupted set of teeth (except for the second and third molars).
- Mild to moderate crowding.
- Good oral hygiene.
Who cannot join
- Any medical or dental conditions that may impede orthodontic treatment.
- Patients with severe crowded or rotated teeth, or partially erupted teeth that will hinder the proper positioning of the brackets or bonding trays.
- Patients with any enamel abnormalities, hypoplastic enamel, white spot lesions.
- Presence of large restorations or carious teeth.
- Presence of supernumerary or impacted teeth or tooth agenesis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Orthodontic Bracket Placement by Using Two Different Protocols of Digitally Aided Bonding (Split-Mouth Randomized Controlled Clinical Trial)
The aim of this study is to compare the accuracy of orthodontic bracket positioning using two different protocols of digitally aided bonding.
- Conditions
- Orthodontic Bracket Placement
- Being tested
- 3D printed indirect bonding trays, 3D printed guiding direct bonding trays
- Keywords
- Orthodontic bonding, Orthodontic bracket positioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed indirect bonding traysOther
Intraoral scan of participants' upper dentition will be obtained. Digital stereolithography models will be used for virtual bracket positioning on software. The digital setup of the brackets will be used for designing the customized indirect bonding transferring tray for one quadrant of the upper arch of each patient.
3D printed guiding direct bonding traysOther
Intraoral scan of participants' upper dentition will be obtained. Digital stereolithography models will be used for virtual bracket positioning on software. The digital setup of the brackets will be used for designing the customized guiding direct bonding tray for the other quadrant of the upper arch of each patient.
| Study group | Role | What they receive |
|---|---|---|
| Indirect bonding group | Experimental | Not described Receives: Other: 3D printed indirect bonding trays |
| Guided direct bonding group | Experimental | Not described Receives: Other: 3D printed guiding direct bonding trays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bracket Placement Accuracy
Measured as the linear and angular deviation between the virtually planned and actual bracket positions using 3D superimposition technique of the digital setup model and intraoral scan after bonding.
Measured: Immediately after bonding
Secondary outcomes (1)
Immediate Bracket Failure
Immediate bracket failure will be assessed for each quadrant during the removal of the bonding trays at the bonding appointment.
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 posted31 Mar 2026
- Study start31 Mar 2026
- Primary completion15 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Bracket PlacementStudies of the same condition, open and under way.
- 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
- Model description
- Split-Mouth Randomized Controlled Clinical Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Alaaeldin Ahmed Fathy Elsaied, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503626
- Sponsor's protocol ID
- 1129-08/2025
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Orthodontic Bracket Placement by Using Two Different Protocols of Digitally Aided Bonding (Split-Mouth Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT07503626
- Acronym / sponsor ID
- 1129-08/2025
- Conditions
- Orthodontic Bracket Placement
- Keywords
- Orthodontic bonding, Orthodontic bracket positioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 31 Mar 2026 (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 aim of this study is to compare the accuracy of orthodontic bracket positioning using two different protocols of digitally aided bonding.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-Mouth Randomized Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Indirect bonding group | Experimental | Other: 3D printed indirect bonding trays |
| Guided direct bonding group | Experimental | Other: 3D printed guiding direct bonding trays |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with permanent dentition starting orthodontic treatment requiring vestibular fixed orthodontic appliance according to treatment needs.
- Fully erupted set of teeth (except for the second and third molars).
- Mild to moderate crowding.
- Good oral hygiene.
Key exclusion criteria (5 listed)
- Any medical or dental conditions that may impede orthodontic treatment.
- Patients with severe crowded or rotated teeth, or partially erupted teeth that will hinder the proper positioning of the brackets or bonding trays.
- Patients with any enamel abnormalities, hypoplastic enamel, white spot lesions.
- Presence of large restorations or carious teeth.
- Presence of supernumerary or impacted teeth or tooth agenesis.
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 |
|---|---|---|
| 3D printed indirect bonding traysIntraoral scan of participants' upper dentition will be obtained. Digital stereolithography models will be used for virtual bracket positioning on software. The digital setup of the brackets will be used for designing the customized indirect bonding transferring tray for one quadrant of the upper arch of each patient. | Other | Indirect bonding group |
| 3D printed guiding direct bonding traysIntraoral scan of participants' upper dentition will be obtained. Digital stereolithography models will be used for virtual bracket positioning on software. The digital setup of the brackets will be used for designing the customized guiding direct bonding tray for the other quadrant of the upper arch of each patient. | Other | Guided direct bonding group |
Primary outcome
Bracket Placement Accuracy
Time frame: Immediately after bonding
Measured as the linear and angular deviation between the virtually planned and actual bracket positions using 3D superimposition technique of the digital setup model and intraoral scan after bonding.
1 secondary outcome
Immediate Bracket Failure
Time frame: Immediately after bonding
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 12 May 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed indirect bonding trays and 3D printed guiding direct bonding trays in people with Orthodontic Bracket Placement, run by Alexandria University at 1 site in Egypt.
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 5 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 12 May 2026. 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 Egypt. 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?
Bracket Placement Accuracy (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 12 May 2026.