Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases

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

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

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliances
• Intervention / Treatment: Device: Acid etched brackets; Device: Sandblasted brackets

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Islamic International Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients about to undergo fixed orthodontic therapy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acid etched brackets; Stainless steel bracket base etched with 10% Hydrofluoric acid for 1 minute	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
Active Comparator: Sandblasted brackets; Stainless steel bracket sandblasted base	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Owais K Durrani, FFDRCSI, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: June 27, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 2, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: IIDC/IRB/06/06/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No