NCT04395625

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

Status unknown NA Last updated 3 November 2022

What this trial tests

NA trial testing Direct bonding of Orthodontic brackets in Orthodontic Appliances, Fixed in 37 participants. Status unknown.

Timeline

30 April 2015

Primary endpoint
30 September 2017

1 June 2024

Quick facts

Lead sponsor	University of Aarhus
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	37
Start date	30 April 2015
Primary completion	30 September 2017
Estimated completion	1 June 2024

Drugs / interventions tested

• Direct bonding of Orthodontic brackets
• Indirect bonding of Orthodontic brackets

Conditions studied

• Orthodontic Appliances, Fixed — all drugs for Orthodontic Appliances, Fixed →

Sponsor

University of Aarhus

Who can join

Eligibility, any sex, with Orthodontic Appliances, Fixed. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.