Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases

Orthodontic Appliances Clinical Trial

Official title:

Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases: A Scanning Electron Microscope Study and an Eighteen Month Randomized Clinical Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456114
• Other study ID #: IIDC/IRB/06/06/2020
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: July 2020
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To describe a method of acid etching the base of a bracket, and to compare the bond failures between micro-abrasive blasted (sandblasted) brackets and acid etched brackets over an eighteen month period

Description:

The aims of this randomized control trial are:

1. To describe a method to chemically etch the bases of stainless steel orthodontic brackets.

2. To observe the changes in the micro-structure of the brackets with sandblasted bases and acid-etched bases under an electron microscope.

3. To compare the failure of orthodontic brackets with a chemical etched base versus a sandblasted base bonded with composite using the conventional acid etch technique, over a follow-up of 18 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients about to undergo fixed orthodontic therapy

Exclusion Criteria:

• Patients with cavities, history of fixed orthodontic therapy, recent bleaching

Related Conditions & MeSH terms

• Orthodontic Appliances

Intervention

Device:
• Acid etched brackets
The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months
• Sandblasted brackets
The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months

Locations

Country	Name	City	State
Pakistan	Islamic International Dental College	Islamabad

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bond Failure Rate	To compare the bond failure rates between acid etched and sandblasted brackets. Done by calculating and comparing the percentages of bracket breakages between the acid etched and sandblasted bracket quadrants.	18 months after placement of brackets on the teeth