The Validity of Customized Orthodontic Bracket Set up
1 other identifier
interventional
30
1 country
1
Brief Summary
CAD/CAM systems have assisted orthodontists in planning and positioning brackets to minimize errors and improve the excellence of treatment. This study aimed to validate measurements obtained from manual and digital systems, as well as evaluate the effectiveness, and periodontal changes that occurred after the treatment. Materials and Methods: This study is a prospective randomized controlled trial, in which clinical evaluation of virtual setup (digital and manual) techniques versus CAD/CAM brackets (Ormco© Insignia™ .022" twin brackets) in terms of expression of bracket prescription and treatment outcome. The sample consisted of 30 young adults with Angle Class I malocclusion. Cone beam computer tomography (CBCT) were obtained before and after the treatment to assess the parallelism between the dental roots and periodontal conditions. Digital impression by three dimensional (3D) intraoral scans (IOS) will be obtained for all participants. The 3D models are converted to stereolithography (STL) for all groups. The sample will be dividing randomly into three groups; the first one treated with CAD/CAM brackets (Ormco© Insignia™ .022" twin brackets), while the other two groups were treated by customization of bracket base of the conventional pre-adjusted twin bracket with orthodontic adhesive material, this will be done through planning and creating the virtual setup by using Maestro® 3D Ortho Studio software. The Indirect bonding devices for the second group will manufacturing from 3D printed models while third group from the manual double-layer vacuum-formed thermoplastic trays. All patients will treat with fixed orthodontic twin brackets appliances. The 3D models of the Virtual setup are comparing with the treated occlusion. The linear and angular measurements are performing by the Geomagic® software and using the 3Shape's Ortho-Analyzer TM software in all groups to assess the American Board of Orthodontics grading system scores. Random errors are assessing by Intra-class Correlation Coefficient (ICC) and method errors. Descriptive statistical analysis, Shapiro-Wilk test to detect the normality of variable distribution and the Chi-square test evaluated whether the ABO scores measurements are within the limits of agreement of each criterion. ABO scores between both groups are analyze by using Wilcoxon test. The Bland-Altman analysis evaluated if differences are within the limits of agreement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2022
CompletedFirst Submitted
Initial submission to the registry
September 13, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedSeptember 23, 2022
September 1, 2022
2 months
September 13, 2022
September 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American Board of Orthodontics (ABO) scoring
scoring system consist of 8 items: 1\. Alignment, 2. Marginal ridge height, 3. Buccolingual inclination, 4. Overjet, 5. Occlusal contacts, 6. Occlusal relationships, 7. Interproximal contacts (1-7) Component: scores \< 0.5 = 0. 0.5 to 1 mm =1. \> 1 mm = 2. 8. Root angulation: Root parallelism = 0. Roots are not parallel = 1. Contacting adjacent tooth = 2. High scores on individual segments, or combinations of individual segments, may cause a case to become Incomplete. SO: the minimum value = 0 the maximum value = 16 the high score means = worse outcome the low score means = better outcome
18 months
Secondary Outcomes (1)
linear and angular measurement of the bracket position
4 months
Study Arms (3)
CAD/CAM Insignia™ brackets
EXPERIMENTALThe result from this group (10 patients) considered as a gold standard for other two groups through assessing the treatment outcomes using American Board of Orthodontics (ABO) scoring.
Software-driven indirect bonding tray
EXPERIMENTALThe first comparison group (10 patients): digital setup, virtual bracket placement and creation of 3D printing indirect bounding tray by using Maestro® 3D Ortho Studio software.
Manual-driven indirect bonding tray
EXPERIMENTALthe second comparison group (10 patients): digital setup by using Maestro® 3D Ortho Studio software, but the bracket positioning done manually by using Ray Set® device. in this group using double-layer vacuum-formed thermoplastic indirect bonding tray.
Interventions
it is metal orthodontic twin brackets with customized base and individual arch-wires for each patient
it is conventional metal orthodontic twin brackets will be customizing the bracket base with adhesive composite, individual arch-wires for each patient and 3D printing indirect bonding tray
it is conventional metal orthodontic twin brackets will be customizing the bracket base with adhesive composite, individual arch-wires for each patient and double-layer vacuum-formed thermoplastic indirect bonding tray
Eligibility Criteria
You may qualify if:
- Class 1 malocclusion.
- Non-extraction treatment plan.
- Initial Little Index between 5-10 mm.
- Presence of all permanent teeth.
You may not qualify if:
- Any systemic diseases such as diabetes, hypertension.
- Sound or clicking in temporomandibular joint or craniofacial syndromes.
- Periodontal disease or pockets greater than 4mm.
- Incisor mandibular plane angle (IMPA) ≥ 100 degrees; or any anterior tooth completely blocked from the arch form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ammar Alubaydilead
Study Sites (1)
collage of dentistry-Baghdad university
Baghdad, 10001, Iraq
Related Publications (1)
Al-Ubaydi AS, Al-Groosh D. Do the Various Indirect Bonding Techniques Provide the Same Accuracy for Orthodontic Bracket Placement? (Randomized Clinical Trial). Int J Dent. 2024 Jan 22;2024:5455197. doi: 10.1155/2024/5455197. eCollection 2024.
PMID: 38288393DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Dheaa H Al-Groosh, phd
collage of dentistry- Baghdad university
- STUDY CHAIR
Ammar S Alubaydi, MSc
collage of dentistry- Baghdad university
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- clinical and lab investigator (orthodontist, PhD student)
Study Record Dates
First Submitted
September 13, 2022
First Posted
September 22, 2022
Study Start
June 3, 2022
Primary Completion
July 30, 2022
Study Completion
September 12, 2022
Last Updated
September 23, 2022
Record last verified: 2022-09