Orthodontic Retention ProceduresORIFNCT04954976
Orthodontic Retention In France - ORIF
An observational study of Orthodontic Retention Procedures, run by Nantes University Hospital at 1 site in France.
Trial summary
The goal of this study is to survey retention procedures used by French orthodontists, and evaluate the needs for practice guidelines. The hypothesis is that there is no consensus among orthodontists, requiring practice homogenization via expert guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthodontic Retention Procedures
- What is being tested?
- Orthodontic retention procedures survey
- How many people
- 262 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jan 2021to 2 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: French orthodontists
Who may be able to join
- All French Specialist orthodontists trained in France who answer the survey
Who cannot join
- Non-specialist orthodontists, not trained in France
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiologic Study of Orthodontic Retention Practices in France
The goal of this study is to survey retention procedures used by French orthodontists, and evaluate the needs for practice guidelines. The hypothesis is that there is no consensus among orthodontists, requiring practice homogenization via expert guidelines. Similar studies have been driven in others European countries (such as Swiss, the Netherlands, Lithuania and Norway), but not in France.
Read the detailed description
Questionnaire aggregating 27 questions on orthodontic retention strategies, was sent to a professional list of French orthodontists from health authorities. The survey was composed of eight parts, about sociodemographic status, retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.
- Conditions
- Orthodontic Retention Procedures
- Being tested
- Orthodontic retention procedures survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic retention procedures surveyOther
The survey was composed of eight parts, about sociodemographic status, retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of technics
Retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.
Measured: Day0 = Response to the Suvey
Description of materials
Retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.
Measured: Day0 = Response to the Suvey
Description of retention strategies used by clinicians.
Retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.
Measured: Day0 = Response to the Suvey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start18 Jan 2021
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Retention ProceduresStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954976
- Sponsor's protocol ID
- AL - RNI ORIF
- Acronym
- ORIF
- Status last verified
- Jul 2021
- First submitted
- 16 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study of Orthodontic Retention Practices in France
- ClinicalTrials.gov ID
- NCT04954976
- Acronym / sponsor ID
- ORIF / AL - RNI ORIF
- Conditions
- Orthodontic Retention Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 8 Jul 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 goal of this study is to survey retention procedures used by French orthodontists, and evaluate the needs for practice guidelines. The hypothesis is that there is no consensus among orthodontists, requiring practice homogenization via expert guidelines. Similar studies have been driven in others European countries (such as Swiss, the Netherlands, Lithuania and Norway), but not in France.
Detailed description
Questionnaire aggregating 27 questions on orthodontic retention strategies, was sent to a professional list of French orthodontists from health authorities. The survey was composed of eight parts, about sociodemographic status, retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- French orthodontists
Key inclusion criteria (1 listed)
- All French Specialist orthodontists trained in France who answer the survey
Key exclusion criteria (1 listed)
- Non-specialist orthodontists, not trained in France
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthodontic retention procedures surveyThe survey was composed of eight parts, about sociodemographic status, retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines. | Other | – |
Primary outcome
Description of technics
Time frame: Day0 = Response to the Suvey
Retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.
Description of materials
Time frame: Day0 = Response to the Suvey
Retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.
Description of retention strategies used by clinicians.
Time frame: Day0 = Response to the Suvey
Retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.
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 8 Jul 2021.
- Individual participant dataSharing planned: No. No IPD
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Retention Procedures, run by Nantes University Hospital 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 8 Jul 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?
Description of technics (time frame: Day0 = Response to the Suvey). The study lists 3 primary outcomes in all. 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 8 Jul 2021.