ACCURACY OF ORTHODONTIC BRACKETS POSITIONING WITH OR WITHOUT DENTAL LOUPES
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Malaya
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- linear measurement (mm) and mesio-distal angulation (degree) dimension on 3D scanned images of brackets position
Study Overview
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:
- Does the usage of dental loupes affect the linear measurement of the bracket positioning during bond-up in patients?
- Does the usage of the dental loupes affect the angular measurement of the bracket positioning during bond-up in patients ?
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Able to maintain good periodontal health with BPE score 0,1 or
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
linear measurement (mm) and mesio-distal angulation (degree) dimension on 3D scanned images of brackets position
Time Frame: 2 weeks
linear measurement (mm) in mesio-distal and occlusal-gingival dimensions mesio-distal angulation dimension (degree) on 3D scanned images of brackets position
Secondary Outcomes
- Alignment of teeth post intervention(up to 6 months)
Investigators
Joel Moh Heng Shu
University Science Malaysia (USM), Doctor of Dental Surgery. Master of Oral Science (Malaya)
University of Malaya
