- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05646277
Patient Reported Experience Measures Following a First Remote Orthodontic Consultation : a Randomized Controlled Trial
December 2, 2022 updated by: Centre Hospitalier Universitaire de Nice
Patient and Practitionners Reported Experience Measures (PREMs) Following a First Remote Orthodontic Consultation Versus a First Face-to-face Orthodontic Consultation
The objective of this present randomized controlled trial was to investigate patient's and practitioner's Reported Outcomes Measures (PROMs) following a first standard face-to-face consultation versus a first orthodontic teleconsultation (video-assisted remote orthodontic consultation).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
60
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
-
-
-
Nice, France, 06300
- CHU de Nice
-
-
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
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients requesting a first orthodontic consultation in the Orthodontics Unit (Odontology, Hospital of Nice)
Description
Inclusion criteria :
- Patients requesting a first orthodontic consultation.
Exclusion criteria :
- children not accompanied by their legal guardian (under 18 years old).
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Test
first remote-assisted orthodontic teleconsultation
|
first orthodontic consultation in remote
|
Control
classic first consultation (face-to-face consultation)
|
first orthodontic consultation in face-to-face
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall patient satisfaction between first remote-assisted orthodontic teleconsultation and classic first consultation
Time Frame: 8 months
|
satisfaction questionnaire
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall practionner satisfaction between first remote-assisted orthodontic teleconsultation and classic first consultation
Time Frame: 8 months
|
satisfaction questionnaire
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
November 1, 2021
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
December 2, 2022
First Submitted That Met QC Criteria
December 2, 2022
First Posted (Estimate)
December 12, 2022
Study Record Updates
Last Update Posted (Estimate)
December 12, 2022
Last Update Submitted That Met QC Criteria
December 2, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 22Odonto01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Not scheduled
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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