Patient Reported Experience Measures Following a First Re... | NCT05646277

Studies
Patient Reported Experience Measures Following a First Remote Orthodontic Consultation : a Randomized Controlled Trial

NCT05646277

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Dec 20, 2024Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Odontologic Disorders

Interventions

e-Consultation
Consultation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2021Actual

Primary Completion Date

Jun 30, 2022Actual

Completion Date

Jun 30, 2022Actual

First Submitted Date

Dec 2, 2022

First Submission Date that Met QC Criteria

Dec 2, 2022

First Posted Date

Dec 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2024

Last Update Posted Date

Dec 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test		first remote-assisted orthodontic teleconsultation	Other: e-Consultation
Control		classic first consultation (face-to-face consultation)	Other: Consultation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
e-Consultation	Other	first orthodontic consultation in remote	Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall patient satisfaction between first remote-assisted orthodontic teleconsultation and classic first consultation	satisfaction questionnaire	8 months

Secondary Outcomes

Measure	Description	Time Frame
Overall practionner satisfaction between first remote-assisted orthodontic teleconsultation and classic first consultation	satisfaction questionnaire	8 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria :

- Patients requesting a first orthodontic consultation.

Exclusion criteria :

- children not accompanied by their legal guardian (under 18 years old).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients requesting a first orthodontic consultation in the Orthodontics Unit (Odontology, Hospital of Nice)

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU de NICE		Nice		06300	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not scheduled

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D014076	Tooth Diseases

ID	Term
D009057	Stomatognathic Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D012017	Referral and Consultation

Ancestor Terms

ID	Term
D011364	Professional Practice
D009934	Organization and Administration
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided