Malocclusion; Displaced TeethNCT07474389
Can Magnification Loupes Make the Bracket Bonding Procedure Faster and More Comfortable?
A study testing Loupes-based bonding and Traditional bonding in people with Malocclusion; Displaced Teeth, run by Damascus University at 1 site in Syria.
Trial summary
This study aims to evaluate whether using 3.5x dental magnification loupes improves the speed and patient comfort of the orthodontic bracket placement procedure in patients with crowded dentition, a condition that can make the process more challenging and potentially uncomfortable. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Malocclusion; Displaced Teeth
- What is being tested?
- Loupes-based bonding and Traditional bonding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSyria
- Study dates
- 23 Aug 2023to 15 Sep 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 18 to 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adults aged 18-28 years
- presence of all permanent teeth,
- the presence of dental crowding,
- sound, intact enamel surfaces on teeth to be bonded,
- good oral hygiene, defined as a Plaque Index ≤ 1
Who cannot join
- the presence of amelogenesis imperfecta, enamel hypoplasia, or white spots affecting the buccal surfaces,
- severe or active periodontal disease,
- congenitally missing teeth,
- prosthetic restorations on the buccal surfaces of teeth to be bonded,
- previous orthodontic re-treatment,
- poor oral hygiene (Plaque Index > 1)
Trial locations and contacts
1 site in 1 country.
Syria1 site
Orthodontics Department, Faculty of Dentistry
Damascus, Rif-dimashq Governorate, DM20AM19
About this study
Official title: A Split-mouth Randomized Controlled Trial Comparing Loupes-assisted Versus Conventional Bonding of Brackets in Terms of Discomfort and Bonding Duration in Crowded Dental Arches.
This study aims to evaluate whether using 3.5x dental magnification loupes improves the speed and patient comfort of the orthodontic bracket placement procedure in patients with crowded dentition, a condition that can make the process more challenging and potentially uncomfortable. We will directly compare the conventional method (unaided vision), which is employed by most orthodontists, with an alternative approach in which the clinician performs bonding while wearing magnification loupes. These loupes provide a clearer and more detailed view of the teeth during the procedure.
Both methods will be applied to the same patient using a split-mouth study design. Our primary goal is to determine which method is faster to perform and which one results in less discomfort for the patient during the appointment.
Read the detailed description
Magnification loupes have become widely used in dental practice, demonstrating superior performance over unaided vision in many specialties such as restorative dentistry, endodontics, and periodontics, primarily by enhancing the operator's precision, ergonomics, and visual acuity. In orthodontics, loupes have also been shown to improve the quality of bracket debonding.
However, the specific role of magnification loupes in potentially modulating the patient's sensory experience immediately after the bonding procedure remains entirely unexplored. It is unknown whether the improved visualization afforded by magnification translates into a more or less comfortable patient experience during bracket placement. The presence of an advanced tool such as loupes may elevate patient expectations, potentially influencing their reported comfort.
Moreover, understanding the patient's immediate comfort is clinically meaningful, as a positive early experience may enhance overall treatment acceptance and cooperation.
- Conditions
- Malocclusion; Displaced Teeth
- Being tested
- Loupes-based bonding, Traditional bonding
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loupes-based bondingProcedure or surgery
Bonding will be done with improved vision with loupes.
Traditional bondingProcedure or surgery
The orthodontist will bond the brackets using the naked-eye method.
| Study group | Role | What they receive |
|---|---|---|
| Loupes-assisted bonding | Experimental | A total of 600 brackets (120 quadrants from 60 patients) will be bonded using 3.5× magnification loupes Receives: Procedure: Loupes-based bonding |
| Unaided-vision bonding | Active comparator | A total of 600 brackets (120 quadrants from 60 patients) will be bonded with the naked eye, without visual aids Receives: Procedure: Traditional bonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported discomfort
Each quadrant will be assessed using a 100 mm Visual Analog Scale (VAS). Immediately after the bonding procedure for each quadrant, patients will be asked to mark their perceived discomfort level on a horizontal line ranging from 0 mm ("no discomfort") to 100 mm ("worst imaginable discomfort"). The exact distance from the 0 mm point to the patient's mark will be measured in millimeters, providing an accurate discomfort score for each quadrant.
Measured: At 5 minutes after bonding the brackets.
Total bonding time
Total bonding time per quadrant will be recorded using the stopwatch function of the Clock application on an iPhone, with time measured in minutes, seconds, and sub-seconds. Recording will start with the initiation of enamel etching and will conclude exactly at the completion of the final light-curing of brackets in each quadrant, representing the total operative time per quadrant.
Measured: This variable is going to be measured once from the beginning of the bonding procedure till the end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start23 Aug 2023
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Malocclusion; Displaced TeethStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai M Faour, DDS, Principal investigator, Department of Orthodontics, Faculty of Dentistry, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474389
- Sponsor's protocol ID
- UDDS-2026-Ortho-01
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Litt MD. A model of pain and anxiety associated with acute stressors: distress in dental procedures. Behav Res Ther. 1996 May-Jun;34(5-6):459-76. doi: 10.1016/0005-7967(96)00015-0.
PubMed 8687368Kono K, Murakami T, Tanizaki S, Kawanabe N, Fujisawa A, Nakamura M, Hoshijima M, Izawa T, Kamioka H. Comprehensive clinical evaluation of indirect and direct bonding techniques in orthodontic treatment: a single-centre, open-label, quasi-randomized controlled clinical trial. Eur J Orthod. 2024 Dec 1;46(6):cjae036. doi: 10.1093/ejo/cjae036.
PubMed 39364772Abdelrahman RSh, Al-Nimri KS, Al Maaitah EF. Pain experience during initial alignment with three types of nickel-titanium archwires: a prospective clinical trial. Angle Orthod. 2015 Nov;85(6):1021-6. doi: 10.2319/071614-498.1.
PubMed 26516711Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
PubMed 2750720Mohanty B, Chekka M, Sowmya C, Khurana R, Manga UM, Varma Datla PK, Somaraj V. Evaluation of Pain and Discomfort Associated with Orthodontic Adjustments. J Pharm Bioallied Sci. 2024 Jul;16(Suppl 3):S2400-S2402. doi: 10.4103/jpbs.jpbs_269_24. Epub 2024 Jul 31.
PubMed 39346332
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Split-mouth Randomized Controlled Trial Comparing Loupes-assisted Versus Conventional Bonding of Brackets in Terms of Discomfort and Bonding Duration in Crowded Dental Arches.
- ClinicalTrials.gov ID
- NCT07474389
- Acronym / sponsor ID
- UDDS-2026-Ortho-01
- Conditions
- Malocclusion; Displaced Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 16 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.
This study aims to evaluate whether using 3.5x dental magnification loupes improves the speed and patient comfort of the orthodontic bracket placement procedure in patients with crowded dentition, a condition that can make the process more challenging and potentially uncomfortable. We will directly compare the conventional method (unaided vision), which is employed by most orthodontists, with an alternative approach in which the clinician performs bonding while wearing magnification loupes. These loupes provide a clearer and more detailed view of the teeth during the procedure.
Both methods will be applied to the same patient using a split-mouth study design. Our primary goal is to determine which method is faster to perform and which one results in less discomfort for the patient during the appointment.
Detailed description
Magnification loupes have become widely used in dental practice, demonstrating superior performance over unaided vision in many specialties such as restorative dentistry, endodontics, and periodontics, primarily by enhancing the operator's precision, ergonomics, and visual acuity. In orthodontics, loupes have also been shown to improve the quality of bracket debonding.
However, the specific role of magnification loupes in potentially modulating the patient's sensory experience immediately after the bonding procedure remains entirely unexplored. It is unknown whether the improved visualization afforded by magnification translates into a more or less comfortable patient experience during bracket placement. The presence of an advanced tool such as loupes may elevate patient expectations, potentially influencing their reported comfort.
Moreover, understanding the patient's immediate comfort is clinically meaningful, as a positive early experience may enhance overall treatment acceptance and cooperation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loupes-assisted bonding | Experimental | Procedure: Loupes-based bondingA total of 600 brackets (120 quadrants from 60 patients) will be bonded using 3.5× magnification loupes |
| Unaided-vision bonding | Active comparator | Procedure: Traditional bondingA total of 600 brackets (120 quadrants from 60 patients) will be bonded with the naked eye, without visual aids |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- adults aged 18-28 years
- presence of all permanent teeth,
- the presence of dental crowding,
- sound, intact enamel surfaces on teeth to be bonded,
- good oral hygiene, defined as a Plaque Index ≤ 1
Key exclusion criteria (6 listed)
- the presence of amelogenesis imperfecta, enamel hypoplasia, or white spots affecting the buccal surfaces,
- severe or active periodontal disease,
- congenitally missing teeth,
- prosthetic restorations on the buccal surfaces of teeth to be bonded,
- previous orthodontic re-treatment,
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 |
|---|---|---|
| Loupes-based bondingBonding will be done with improved vision with loupes. | Procedure or surgery | Loupes-assisted bonding |
| Traditional bondingThe orthodontist will bond the brackets using the naked-eye method. | Procedure or surgery | Unaided-vision bonding |
Primary outcome
Patient-reported discomfort
Time frame: At 5 minutes after bonding the brackets.
Each quadrant will be assessed using a 100 mm Visual Analog Scale (VAS). Immediately after the bonding procedure for each quadrant, patients will be asked to mark their perceived discomfort level on a horizontal line ranging from 0 mm ("no discomfort") to 100 mm ("worst imaginable discomfort"). The exact distance from the 0 mm point to the patient's mark will be measured in millimeters, providing an accurate discomfort score for each quadrant.
Total bonding time
Time frame: This variable is going to be measured once from the beginning of the bonding procedure till the end.
Total bonding time per quadrant will be recorded using the stopwatch function of the Clock application on an iPhone, with time measured in minutes, seconds, and sub-seconds. Recording will start with the initiation of enamel etching and will conclude exactly at the completion of the final light-curing of brackets in each quadrant, representing the total operative time per quadrant.
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 16 Mar 2026.
- Background: PubMed 8687368Litt MD. A model of pain and anxiety associated with acute stressors: distress in dental procedures. Behav Res Ther. 1996 May-Jun;34(5-6):459-76. doi: 10.1016/0005-7967(96)00015-0.
- Background: PubMed 39364772Kono K, Murakami T, Tanizaki S, Kawanabe N, Fujisawa A, Nakamura M, Hoshijima M, Izawa T, Kamioka H. Comprehensive clinical evaluation of indirect and direct bonding techniques in orthodontic treatment: a single-centre, open-label, quasi-randomized controlled clinical trial. Eur J Orthod. 2024 Dec 1;46(6):cjae036. doi: 10.1093/ejo/cjae036.
- Background: PubMed 26516711Abdelrahman RSh, Al-Nimri KS, Al Maaitah EF. Pain experience during initial alignment with three types of nickel-titanium archwires: a prospective clinical trial. Angle Orthod. 2015 Nov;85(6):1021-6. doi: 10.2319/071614-498.1.
- Background: PubMed 2750720Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
- Background: PubMed 39346332Mohanty B, Chekka M, Sowmya C, Khurana R, Manga UM, Varma Datla PK, Somaraj V. Evaluation of Pain and Discomfort Associated with Orthodontic Adjustments. J Pharm Bioallied Sci. 2024 Jul;16(Suppl 3):S2400-S2402. doi: 10.4103/jpbs.jpbs_269_24. Epub 2024 Jul 31.
- Individual participant dataSharing planned: No
Related trials for Malocclusion; Displaced Teeth
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Not yet recruiting
Augmented Reality Dentistry
Edentulism, Malocclusion; Displaced Teeth
Recruiting
3-D Evaluation of Alveolar Bone Changes and Root Resorption After Traction of Buccally Displaced Maxillary Canines
Malocclusion; Displaced Teeth
Active, not recruiting
Orthodontic Treatment in Adolescents With Crowding and Displaced Teeth
Crowding, Tooth, Orthodontic
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.
Mai M Faour, DDS principal investigator
Department of Orthodontics, Faculty of Dentistry, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loupes-based bonding and Traditional bonding in people with Malocclusion; Displaced Teeth, run by Damascus University at 1 site in Syria.
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 5 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: finished, as of the sponsor's last update on 16 Mar 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 Syria. 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?
Patient-reported discomfort (time frame: At 5 minutes after bonding the brackets.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07474389, which also lists 5 linked publications.
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 16 Mar 2026.