Study Aimed at Detecting Potential Abuse of Nitrous Oxide... | NCT02894463

Studies
Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care

NCT02894463

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Jun 24, 2026Actual

Enrollment

76Actual

Phase

Not provided

Conditions

Periodontal Disease

Interventions

questionnaire

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

Aug 2016

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 2014

Primary Completion Date

May 2015Actual

Completion Date

May 2015Actual

First Submitted Date

Aug 11, 2016

First Submission Date that Met QC Criteria

Sep 8, 2016

First Posted Date

Sep 9, 2016Estimated

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

Jun 23, 2026

Last Update Posted Date

Jun 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the potential risk of abusive behavior for children in care using nitrous oxide for dental care.

Detailed Description

The expected prospects are therefore maintaining surveillance around the MEOPA following his release from hospital reserves, but also to ensure that the MEOPA not an addictive potential in the context of its use in dentistry. The results of this study will in any case to secure its application for dental care.

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

76Actual

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
presence of clear signs that the child is trying to extend the contact MEOPA ( questionnaire )	hand gesture to keep the mask over the nose and / or mouth, verbalization of the desire to keep the mask over the nose and / or mouth, to extend the negotiation contac	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 3 to 15 years
Requiring dental care under MEOPA
Not opposing, as well as his parents, his participation in the study
Not having difficulties tracking (going on holiday, imminent change, remoteness, lack of motivation)

Exclusion Criteria:

Excluded patients are those whose dental care can be made to the vigil state, or on the contrary, will present a number of important care, justifying general anesthesia.

Also excluded will be children whose parents no longer have parental authority or whose parents are divorced or divorcing.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

All patients seen in consultation EMENO and being younger than 15 years will be offered this study.

This is a population of non-cooperative patients to dental care or with a disability limiting their cooperation.

A quick questionnaire will be submitted in the consultations EMENO the SSC, the children after their parents' permission.

Sampling Method

Probability Sample

Name	Affiliation	Role
Tony Prud'homme, Dr	Nantes University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Nantes		Nantes		44093	France

ID	Term
D010510	Periodontal Diseases

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided