Orthodontic Appliance ComplicationNCT05042843
Effect of Deproteinization on the Shear Bond Strength and Glue Penetration in the Enamel of Orthodontic Brackets
An observational study of Orthodontic Appliance Complication, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Orthodontic Appliance Complication
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 30 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patient with orthodontic treatment involving bicupids extractions
Who may be able to join
- All patient with orthodontic treatment involving bicupids extractions
Who cannot join
- Patients with damaged teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Orthodontic Appliance Complication
- Keywords
- glue penetration, orthodontic brackets, self-etching bracket
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of resistance to tearing of orthodontic brackets stuck to extracted premolars
Number of resistance to tearing of orthodontic brackets stuck to extracted premolars
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 May 2019
- Primary completion1 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphane BARTHELEMI, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042843
- Sponsor's protocol ID
- RECHMPL21_0534
- Status last verified
- Sep 2021
- First submitted
- 1 Sep 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05042843
- Acronym / sponsor ID
- RECHMPL21_0534
- Conditions
- Orthodontic Appliance Complication
- Keywords
- glue penetration, orthodontic brackets, self-etching bracket
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patient with orthodontic treatment involving bicupids extractions
Key inclusion criteria (1 listed)
- All patient with orthodontic treatment involving bicupids extractions
Key exclusion criteria (1 listed)
- Patients with damaged teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: Undecided. NC
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The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphane BARTHELEMI, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthodontic Appliance Complication, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of resistance to tearing of orthodontic brackets stuck to extracted premolars (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.