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Bracket BondingNCT07134803

ACCURATE ORTHODONTIC BRACKETS POSITIONING WITH OR WITHOUT DENTAL MAGNIFYING LOUPES

A study testing Bonding of the orthodontic brackets with dental loupe with Zumax Dental loupes DFK Angled Loupe with a magnification of x3.0 and focus depth of 42cm in people with Bracket Bonding and Digital Application, run by University of Malaya at 1 site in Malaysia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to assess the accuracy of bracket positioning on tooth facial axis of clinical crown with dental loupes (L) or without dental loupes (NL) on orthodontic patients. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Bonding of the orthodontic brackets with dental loupe with Zumax Dental loupes DFK Angled Loupe with a magnification of x3.0 and focus depth of 42cm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteMalaysia
Study dates
2 Oct 2024to 30 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able to maintain good periodontal health with BPE score 0,1 or 2.
  • Healthy teeth without fractures, abrasions, size-shape abnormalities, or poor morphology
  • Fully erupted and complete permanent dentition from right to left premolars on maxillary and mandibular arches.
  • Overbite and overjet that allowed brackets to be placed on the lower teeth without occlusal interferences.
  • Mild and moderate crowding < 8.0 mm.

Who cannot join

  • Patient with craniofacial disorders (e.g. cleft lip and palate, craniofacial syndromes)
  • Clinically visible dental caries, proximal restorations (Class II amalgam or composite), build-ups, crowns, onlays that affect the tooth's mesiodistal diameter.
  • Patients that required maxillary and mandibular anterior tooth extraction
  • Congenital defects or deformed teeth
  • Obvious interproximal or occlusal wear of teeth
  • Severe crowding (severe overlapping unable to place bracket)
Show all 9Show fewer
  • Infraocclusion, gingival hyperplasia
  • Patient that requires sectional mechanics or brackets swapping mechanics in orthodontic treatment.
  • Traumatic extraction

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Department of Paediatric Dentistry and Orthodontics, Faculty of Dentistry, Universiti Malaya

    Kuala Lumpur, 50603

Other trials in Malaysia

About this study

Official title: ACCURACY OF ORTHODONTIC BRACKETS POSITIONING WITH OR WITHOUT DENTAL LOUPES

The goal of this clinical trial is to assess the accuracy of bracket positioning on tooth facial axis of clinical crown with dental loupes (L) or without dental loupes (NL) on orthodontic patients. The main questions it aims to answer are:

  1. Does the usage of dental loupes affect the linear measurement of the bracket positioning during bond-up in patients?
  2. Does the usage of the dental loupes affect the angular measurement of the bracket positioning during bond-up in patients ?
Read more

Researchers will compare group that use dental loupes and without dental loupes to a gold standard.

Participants will

  • Be addressed a treatment plan tailored to their malocclusion.
  • Take an intraoral scan with an intraoral scanner 3Shape TRIOS, Copenhagen, Denmark.
  • Attend bond up session that was scheduled within a week time once the gold standard for individual patient was generated.
  • Take second intraoral scan after bracket bonding
Read the detailed description

Interventions

This was a two-arm parallel, singe-centre randomised study where the patients that have been treatment planned were randomised into two groups according to the block pattern:

Group NL: Bonding of the orthodontic brackets without dental loupe Group L: Bonding of the orthodontic brackets with dental loupe After extraction procedure was performed according to treatment plan. Within a week, the patient's teeth were dried before taking an intraoral scan with an intraoral scanner 3Shape TRIOS, Copenhagen, Denmark. After scanning the upper and lower arches, the teeth images were stored in STL file. STL file is a format commonly used for 3D printing and computer-aided design (CAD).

The STL file of each patient upper and lower arches were exported and printed into model by the 3D printer by digital dental laboratory to allow extraoral bracket positioning. The extraoral bracket positioning on the twenty 3D printed models were the gold standard for the eighteen patients respectively.

Once the gold standard for individual patient was generated, the bond up session was scheduled within a week time, a new set of brackets were placed by MJHS on the patient's maxillary and mandibular right to left premolars. Bonding of the brackets was performed according to the manufacturer's instructions. Dental loupes Zumax DFK Angled Loupe with a magnification of x3.0 and focus depth of 42cm was used. For the patients bond up by direct eye vision or using dental loupes, the brackets were positioned in the centre of mesial-distal dimension and aligned with the long axis of the crown. No over-correction of the bracket positioning was done to correct specific malocclusions, rotation, or tipping problems. After 40s light-curing of the composite according to manufacturer instructions. The bracket bonding was performed by MJHS in all patients to avoid inter-operator errors.

After bracket bonding, the postoperative dentitions was dried, and scanned with intraoral scanner for T2 by MJHS. Independent assistant (MM) coded the patients scanned STL files which were preoperative (3D images of T1 as gold standard) and postoperative 3D images as a pair without the knowledge of the principal investigator. The software identified 4 identical points on the same teeth from each pair of files and align for superimposition. The different bracket position was shown on the computer's screen in different colours. The differences in mesio-distal (MD) and occlusal-gingival (OG) dimensions, as well as mesio-distal angulation (MDang) dimensions were measured at magnification x10 of superimposition.

To measure the difference in bracket placement between the 2 methods employed the comparison between file preoperative and file postoperative, positive and negative signs were used for distances (distal: +; mesial: -; gingival: +; occlusal: -) and angulation (distal: +; mesial: -). Measurements included all the teeth in the inclusion criteria (Mohammadi \& Moslemzadeh, 2011; Panayi et al., 2020).

After the last 0.018" NiTi archwire for full expression of alignment archwire, the patients' teeth again scanned to assess the alignment of the teeth, T3. A crowding score based on the mesio-distal width for the maxillary and mandibular teeth will be measured in millimeters at T3 compared to T2 in relation to the line of arch that reflects the majority of teeth (Kirschen et al., 2000). The alignment of the patients' teeth with be categorized using Little's Irregularity Index into five categories based on a numerical score: 0 indicates perfect alignment, 1-3 is minimal irregularity, 4-6 is moderate irregularity, 7-9 is severe irregularity, and 10 or more is very severe irregularity. This index quantifies the degree of anterior crowding by measuring the sum of linear displacements (mm) of anatomical contact points of six anterior teeth. Any bracket that dislodged from the teeth was bonded back and kept in record. Bracket off was bonded according to the intervention the patient received. The leveling and alignment phase was considered accomplished when 0.019x0.025-inch stainless steel (SS) wire could be inserted without applying an exaggerated force (Al-Ibrahim et al., 2023). The dropout criteria was defined BPE score more than 2.

Being tested
Bonding of the orthodontic brackets with dental loupe with Zumax Dental loupes DFK Angled Loupe with a magnification of x3.0 and focus depth of 42cm
Keywords
Bracket Positioning, Dental Loupes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bonding of the orthodontic brackets with dental loupe with Zumax Dental loupes DFK Angled Loupe with a magnification of x3.0 and focus depth of 42cmDevice

    Bonding of the orthodontic brackets on patients' teeth with dental loupe with Zumax Dental loupes DFK Angled Loupe with a magnification of x3.0 and focus depth of 42cm. Then the scanned for STL file and be superimposed with the gold standard created for the patient individually.

Study groups in NCT07134803
Study groupRoleWhat they receive
Group NL: Bonding of the orthodontic brackets without dental loupeNo interventionBonding of the orthodontic brackets on patients' teeth without dental loupe
Group L: Bonding of the orthodontic brackets with dental loupeActive comparatorBonding of the orthodontic brackets on patients' teeth with dental loupe
Receives: Device: Bonding of the orthodontic brackets with dental loupe with Zumax Dental loupes DFK Angled Loupe with a magnification of x3.0 and focus depth of 42cm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. linear measurement (mm) and mesio-distal angulation (degree) dimension on 3D scanned images of brackets position

    linear measurement (mm) in mesio-distal and occlusal-gingival dimensions

    mesio-distal angulation dimension (degree) on 3D scanned images of brackets position

    Measured: 2 weeks

Secondary outcomes (1)
  1. Alignment of teeth post intervention

    assess the alignment of patients' maxillary and mandibular teeth from right to left premolars at the end of levelling and aligning stage between with and without dental loupes intervention groups. The alignment of the patients' teeth with be categorized using Little's Irregularity Index into five categories based on a numerical score: 0 indicates perfect alignment, 1-3 is minimal irregularity, 4-6 is moderate irregularity, 7-9 is severe irregularity, and 10 or more is very severe irregularity. This index quantifies the degree of anterior crowding by measuring the sum of linear displacements (mm) of anatomical contact points of six anterior teeth.

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start2 Oct 2024
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Oct 2025 (estimated)

Resources

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
Model description
This was a two-arm parallel, singe-centre randomised study where the patients that have been treatment planned were randomised into two groups according to the block pattern: Group NL: Bonding of the orthodontic brackets without dental loupe Group L: Bonding of the orthodontic brackets with dental loupe
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07134803
Sponsor's protocol ID
UMG050E-2024
Other IDs
UMG050E-2024
Status last verified
Aug 2025
First submitted
7 Aug 2025
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No, we do not plan to share individual participant data (IPD). The dataset will not be made publicly available due to concerns about participant privacy and data sensitivity.

Questions about this trial

What is this clinical trial studying?

A study testing Bonding of the orthodontic brackets with dental loupe with Zumax Dental loupes DFK Angled Loupe with a magnification of x3.0 and focus depth of 42cm in people with Bracket Bonding and Digital Application, run by University of Malaya at 1 site in Malaysia.

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 9 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: under way, not looking for participants, as of the sponsor's last update on 21 Aug 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 Malaysia. 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?

This study is still under way. Results are not available in the source record yet.

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 measurement (mm) and mesio-distal angulation (degree) dimension on 3D scanned images of brackets position (time frame: 2 weeks). 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 Aug 2025.

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