Micro-abrasive Blasting vs Acid Etching of Orthodontic Bracket Bases

NCT ID: NCT04456114

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-01-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Orthodontic Appliances

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel-group, split mouth, triple blinded, randomized control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acid etched brackets

Stainless steel bracket base etched with 10% Hydrofluoric acid for 1 minute

Group Type EXPERIMENTAL

Acid etched brackets

Intervention Type DEVICE

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

Stainless steel bracket sandblasted base

Group Type ACTIVE_COMPARATOR

Sandblasted brackets

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients about to undergo fixed orthodontic therapy

Exclusion Criteria

* Patients with cavities, history of fixed orthodontic therapy, recent bleaching
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Owais Khalid Durrani

Professor of Orthodonitcs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Owais K Durrani, FFDRCSI

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Islamic International Dental College

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IIDC/IRB/06/06/2020

Identifier Type: -

Identifier Source: org_study_id

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