Dental BondingNCT05193708
Comparison of Bracket Bonding Variables Using 3D Printed Bonding Guide Versus Digital Indirect Bonding
A study testing Windowed Bonding and Digital Indirect bonding tray in people with Dental Bonding and Orthodontic Brackets, run by Cairo University at 1 site in Egypt.
Trial summary
The windowed direct-indirect bonding is a new bonding technique that could provide a simple and cheap method for fast and precise brackets bonding. There are still not enough studies to evaluate the effectiveness of this method in terms of accuracy, bonding time, bonding failure and cost. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Dental Bonding, Orthodontic Brackets, Indirect Bonding
- What is being tested?
- Windowed Bonding and Digital Indirect bonding tray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Oct 2022to 22 Apr 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- - Patients who need Orthodontic treatment with full dentition excluding 3rd molars.
- Fully erupted 5-5 with normal anatomy.
- The patient's age range is from 12 to 60 years of age.
- Both extraction and non-extraction cases are included.
Who cannot join
- - Patients with caries, fluorosis, enamel hypoplasia, restorations, or fractures.
- Patients with severe rotations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Bracket Bonding Variables Using Bonding Guide 3D Printed With Fusion Deposition Modeling Versus Digital Indirect Bonding. A Randomized Controlled Trial.
The windowed direct-indirect bonding is a new bonding technique that could provide a simple and cheap method for fast and precise brackets bonding. There are still not enough studies to evaluate the effectiveness of this method in terms of accuracy, bonding time, bonding failure and cost.
This study is designed to answer these questions and compare the forementioned bonding technique with digital indirect bonding and finally provide the clinician a recommendation on the best bonding technique. This study introduces as well a new method of fabrication of the windowed template using Fusion Deposition Modeling (FDM) 3D printing technology.
Read the detailed description
This study will compare two bonding techniques, the windowed bonding technique and digital indirect bonding. They will be compared regarding accuracy, bonding time, bonding failure and cost. Patients will be selected according to the eligibility criteria, random sequence generation and blind allocation will be performed. ( A randomized clinical trial). Patients will be allocated to one of the groups either the windowed bonding or the digital indirect bonding.
Both groups will undergo similar steps initially. First, the patient's teeth will be digitized using an intraoral scanner. Then using 3 shape software, the model will be prepared and brackets will be positioned virtually on the 3D models. Then, in the windowed bonding technique, the windowed tray will be designed and later 3D printed, while in the digital indirect technique the model with the brackets will be 3D printed and a tray will be fabricated on the model manually.
After the fabrication of the tray, the brackets will be transferred to the patient using the tray or directly bonded using the windowed tray guide.
The patient's teeth will be scanned after bonding and this 3D model will be compared with the initial brackets setup that was made previously on the software.
- Conditions
- Dental Bonding, Orthodontic Brackets, Indirect Bonding
- Being tested
- Windowed Bonding, Digital Indirect bonding tray
- Keywords
- digital indirect, windowed bonding tray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Windowed BondingDevice
A 3D printed tray/guide with open window for the orthodontic brackets
Digital Indirect bonding trayDevice
Vacuum formed on a 3d printer cast with brackets
| Study group | Role | What they receive |
|---|---|---|
| Digital Indirect bonding | Active comparator | An indirect bonding tray will be fabricated from a 3D printed model Receives: Device: Windowed Bonding |
| Windowed Bonding technique | Experimental | 3D printed guide with windows for positioning the bracket Receives: Device: Digital Indirect bonding tray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bonding accuracy
Deterring the accuracy of bracket position
Measured: After bonding immediately
Secondary outcomes (1)
Bonding time
Calculating the time of bonding
Measured: Time begins starting from etching procedure till the final bracket cured, this will be measured in minutes (~ 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start22 Oct 2022
- Primary completion1 Jan 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelhady Nasef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193708
- Sponsor's protocol ID
- 777
- Status last verified
- Aug 2024
- First submitted
- 3 Jan 2022
- Last updated
- 27 Jun 2025
- 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bracket Bonding Variables Using Bonding Guide 3D Printed With Fusion Deposition Modeling Versus Digital Indirect Bonding. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05193708
- Acronym / sponsor ID
- 777
- Conditions
- Dental Bonding, Orthodontic Brackets, Indirect Bonding
- Keywords
- digital indirect, windowed bonding tray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 Oct 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 22 Apr 2025 (actual)
- First posted
- 18 Jan 2022 (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 windowed direct-indirect bonding is a new bonding technique that could provide a simple and cheap method for fast and precise brackets bonding. There are still not enough studies to evaluate the effectiveness of this method in terms of accuracy, bonding time, bonding failure and cost.
This study is designed to answer these questions and compare the forementioned bonding technique with digital indirect bonding and finally provide the clinician a recommendation on the best bonding technique. This study introduces as well a new method of fabrication of the windowed template using Fusion Deposition Modeling (FDM) 3D printing technology.
Detailed description
This study will compare two bonding techniques, the windowed bonding technique and digital indirect bonding. They will be compared regarding accuracy, bonding time, bonding failure and cost. Patients will be selected according to the eligibility criteria, random sequence generation and blind allocation will be performed. ( A randomized clinical trial). Patients will be allocated to one of the groups either the windowed bonding or the digital indirect bonding.
Both groups will undergo similar steps initially. First, the patient's teeth will be digitized using an intraoral scanner. Then using 3 shape software, the model will be prepared and brackets will be positioned virtually on the 3D models. Then, in the windowed bonding technique, the windowed tray will be designed and later 3D printed, while in the digital indirect technique the model with the brackets will be 3D printed and a tray will be fabricated on the model manually.
After the fabrication of the tray, the brackets will be transferred to the patient using the tray or directly bonded using the windowed tray guide.
The patient's teeth will be scanned after bonding and this 3D model will be compared with the initial brackets setup that was made previously on the software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Indirect bonding | Active comparator | Device: Windowed BondingAn indirect bonding tray will be fabricated from a 3D printed model |
| Windowed Bonding technique | Experimental | Device: Digital Indirect bonding tray3D printed guide with windows for positioning the bracket |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- - Patients who need Orthodontic treatment with full dentition excluding 3rd molars.
- Fully erupted 5-5 with normal anatomy.
- The patient's age range is from 12 to 60 years of age.
- Both extraction and non-extraction cases are included.
Key exclusion criteria (2 listed)
- - Patients with caries, fluorosis, enamel hypoplasia, restorations, or fractures.
- Patients with severe rotations.
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 |
|---|---|---|
| Windowed BondingA 3D printed tray/guide with open window for the orthodontic brackets | Device | Digital Indirect bonding |
| Digital Indirect bonding trayVacuum formed on a 3d printer cast with brackets | Device | Windowed Bonding technique |
Primary outcome
Bonding accuracy
Time frame: After bonding immediately
Deterring the accuracy of bracket position
1 secondary outcome
Bonding time
Time frame: Time begins starting from etching procedure till the final bracket cured, this will be measured in minutes (~ 20 minutes)
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 27 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Windowed Bonding and Digital Indirect bonding tray in people with Dental Bonding and Orthodontic Brackets, run by Cairo 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 2 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 27 Jun 2025. 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?
Bonding accuracy (time frame: After bonding immediately). 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 27 Jun 2025.