Effect of Deproteinization on the Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets

September 6, 2021 updated by: University Hospital, Montpellier

Effect of 5,25% Sodium Hypochlorite Enamel Deproteinization on the Initial Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets Bonded With a Self-etching Primer: An In Vitro Study on Human Bicuspids.

The aim of this study was to evaluate the effects of enamel deproteinization on the initial shear bond strength (SBS) and on the bracket/adhesive failure mode of orthodontic brackets bonded with a self-etching primer (SEP) as a primary objective. As secondary objective a Raman microscopy study was performed to assess the resin penetration into the enamel according to the three bonding protocols.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • UHMontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patient with orthodontic treatment involving bicupids extractions

Description

Inclusion criteria:

- All patient with orthodontic treatment involving bicupids extractions

Exclusion criteria:

- Patients with damaged teeth

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of resistance to tearing of orthodontic brackets stuck to extracted premolars
Time Frame: 1 day
Number of resistance to tearing of orthodontic brackets stuck to extracted premolars
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: Stéphane BARTHELEMI, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ACTUAL)

January 1, 2020

Study Completion (ACTUAL)

January 30, 2020

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 6, 2021

First Posted (ACTUAL)

September 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 6, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL21_0534

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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