ACCURATE ORTHODONTIC BRACKETS POSITIONING WITH OR WITHOUT DENTAL MAGNIFYING LOUPES

NCT07134803 | Active Not Recruiting

• 1 other identifier: UMG050E-2024
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Conditions

Bracket Bonding; Digital Application; Technology-enhanced Learning

Keywords

Bracket Positioning; Dental Loupes

Outcome Measures

Primary Outcomes (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

  2 weeks

Secondary Outcomes (1)

• Alignment of teeth post intervention

  up to 6 months

Study Arms (2)

Group NL: Bonding of the orthodontic brackets without dental loupe

NO INTERVENTION

Bonding of the orthodontic brackets on patients' teeth without dental loupe

Group L: Bonding of the orthodontic brackets with dental loupe

ACTIVE COMPARATOR

Bonding of the orthodontic brackets on patients' teeth with dental loupe

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

Interventions

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 DEVICE

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.

Group L: Bonding of the orthodontic brackets with dental loupe

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• Infraocclusion, gingival hyperplasia
• Patient that requires sectional mechanics or brackets swapping mechanics in orthodontic treatment.
• Traumatic extraction

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Department of Paediatric Dentistry and Orthodontics, Faculty of Dentistry, Universiti Malaya

Kuala Lumpur, 50603, Malaysia

Location

Study Officials

• Siti Adibah Othman Senior Consultant in Orthodontics, BDS (Malaya), DDS (Bristol)

  Department of Paediatric Dentistry and Orthodontics, Faculty of Dentistry, Universiti Malaya

  PRINCIPAL INVESTIGATOR

• Roziana Mohd Razi Senior Lecturer & Specialist Orthodontist, BDS (Malaya), MClinDent(Ortho)

  Department of Paediatric Dentistry and Orthodontics, Faculty of Dentistry, Universiti Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Science Malaysia (USM), Doctor of Dental Surgery. Master of Oral Science (Malaya)

Model Details: 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

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 21, 2025
• Study Start: October 2, 2024
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)