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

NCT04395625 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-11-03

No results posted yet for this study

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

Interventions

PROCEDURE

Direct bonding of Orthodontic brackets

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

PROCEDURE

Indirect bonding of Orthodontic brackets

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.

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-09-30
Completion
2024-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04395625 on ClinicalTrials.gov