Computer-aided Indirect Bonding Versus Traditional Direct Bonding of Brackets in Orthodontic Patients

NCT04395625 | Unknown

• 1 other identifier: 10101
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

Accurate bracket positioning is one of the keys for effective orthodontic treatment. Traditionally, orthodontic brackets are positioned one-by-one on the teeth of the patient, with the so-called direct bonding method. In the past, the term indirect bonding defined a technique where the brackets were positioned on a plaster model in order to increase placement precision. A transfer tray was then built on the plaster, incorporating all the brackets mounted. Finally, this transfer tray was positioned in the mouth of the patient, so that all the brackets could be bonded to the teeth at once in the pre-determined position. Several studies have investigated this indirect technique based on plaster models. With computer-aided technology, a new form of digital indirect bonding is now possible. The dentist digitally places the brackets on a virtual 3D model of the teeth. A tray with the brackets' positioning information is then generated with CAD-CAM (computer aided design and manufacturing) technology and the brackets are subsequently indirectly transferred to the teeth. This new approach could possibly save chair time and increase precision. Our profession is today moving towards the virtual reality, and application of such a computer-aided technology method into the clinical work-flow seems definitely promising for our future daily practice. Since the evidence about this new computer-assisted indirect bracket bonding method is very limited, the purpose of this study is to evaluate precision, chair time, and bracket survival by comparing this digital indirect bonding method to the traditional direct bonding method Specific objectives

• To assess and compare the accuracy of a conventional direct bonding method with an indirect computer-aided bonding method.
• To evaluate chair time and bracket survival related to both bonding methods. Hypothesis Null hypothesis: I. There is no difference in accuracy of bracket placement between the direct and indirect bonding methods. II. There is no difference in chair time between the two bonding methods. III. Bracket bond failure is similar for both bonding methods. Alternative hypothesis: I. Bracket placement is more precise/accurate with the indirect bonding method compared to the traditional direct bonding method. II. Indirect bonding reduces chair time.

Conditions

Orthodontic Appliances, Fixed

Keywords

Indirect bonding; CAD/CAM; Time; Cost-minimization analysis; Failure rate

Outcome Measures

Primary Outcomes (1)

• Time

  Time used for bonding brackets with the CAD/CAM indirect and the traditional direct bonding techniques

  On the day the brackets are bonded (bonding date): within 24 hours

Secondary Outcomes (7)

• Immediate bracket failure rate

  On the day the brackets are bonded (bonding date): within 24 hours

• Cost-minimization analysis

  On the day the brackets are bonded (bonding date): within 24 hours

• Overall bracket failure rate

  From the day the brackets are bonded (bonding date) to the day the brackets are removed (debonding date), generally about 2 years later.

• Bracket position accuracy according to position of the teeth

  From the day the brackets are bonded (bonding date) to the day the brackets are removed (debonding date), generally about 2 years later.

• Bracket position accuracy according to axes of the roots

  From the day the brackets are bonded (bonding date) to the day the brackets are removed (debonding date), generally about 2 years later.

Study Arms (2)

Group 1

EXPERIMENTAL

Patients had their upper right and lower left quadrants bonded with indirect bonding, and their upper left and lower right quadrants with direct bonding.

Procedure: Direct bonding of Orthodontic brackets; Procedure: Indirect bonding of Orthodontic brackets

Group 2

EXPERIMENTAL

Patients had their upper left and lower right quadrants bonded with indirect bonding, and their upper right and lower left quadrants with direct bonding.

Procedure: Direct bonding of Orthodontic brackets; Procedure: Indirect bonding of Orthodontic brackets

Interventions

Direct bonding of Orthodontic brackets PROCEDURE

Patients in group 1 had their upper right and lower left quadrants bonded with indirect bonding, and their upper left and lower right quadrants with direct bonding

Group 1; Group 2

Indirect bonding of Orthodontic brackets PROCEDURE

Patients in group 2 had their upper left and lower right quadrants bonded with indirect bonding, and their upper right and lower left quadrants with direct bonding.

Group 1; Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients selected to be suitable for full fixed appliance according to treatment needs and accepting to have metallic brackets.
• Presence of minimum four permanent teeth (except molars) to be bonded in each of the 4 quadrants (thus extraction or non-extraction cases)
• All teeth fully erupted.

You may not qualify if:

• Patients with teeth presenting active caries, fluorosis or hypoplasia of enamel, restorations or fractures of the surfaces to be bonded, or abnormalities in crown morphology of the teeth to be bonded.
• Subjects with major rotations impeding proper bracket positioning.

Sponsors & Collaborators

• University of Aarhus: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During data analysis, anonymization is ensured by assigning a number to each patient, so that the investigator is blinded to the patient's group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center 2-arm parallel randomized controlled trial with a 1:1 allocation ratio, following a split-mouth design.

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 20, 2020
• Study Start: April 30, 2015
• Primary Completion: September 30, 2017
• Study Completion: June 1, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share