Use of 50% Nitrous Oxide / 50% Oxygen Premix in Primary C... | NCT00643838

Studies
Use of 50% Nitrous Oxide / 50% Oxygen Premix in Primary Care Dental Centers

NCT00643838

Sponsor

Air Liquide Santé International

Status

Completed

Last Update Posted

Sep 15, 2025Actual

Enrollment

549Actual

Phase

Phase 3

Conditions

Dental Cares

Interventions

Kalinox 170 bar

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

Jan 2009

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

Dec 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Mar 20, 2008

First Submission Date that Met QC Criteria

Mar 20, 2008

First Posted Date

Mar 26, 2008Estimated

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

Sep 9, 2025

Last Update Posted Date

Sep 15, 2025Actual

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

A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of dental cares. This openly clinical trial is done in 36 French primary care dental centers, especially on anxious and phobic patients but also on infants or mental deficient adults. At least 480 patients will be included in this clinical protocol.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

549Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Misture of 50% nitrous oxide and 50% oxygen	Drug: Kalinox 170 bar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Kalinox 170 bar	Drug	Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)		At the end of the dental care

Secondary Outcomes

Measure	Description	Time Frame
Patient's acceptance and doctor's satisfaction		At the end of dental care

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

anxious and/or phobic patients having a vomiting reflex
very young children requiring selective dental cares
mental deficient patient
patient having specific phobia linked to the dental care to be done
patient from 1 year old
ASA 1 or ASA 2 patient
existing of efficient contraception

Exclusion Criteria:

ASA 3 or ASA 4 patient
patient already treated without using Kalinox's sedation
patient already included in this protocol in a delay lower than 7 days
contraindication linked to the experimental product
Kalinox's inhalation duration higher than 1 hour
pregnant or breast-feeding women

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Primary dental care centers		Clermont-Ferrand			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22186944	Result	Hennequin M, Collado V, Faulks D, Koscielny S, Onody P, Nicolas E. A clinical trial of efficacy and safety of inhalation sedation with a 50% nitrous oxide/oxygen premix (Kalinox) in general practice. Clin Oral Investig. 2012 Apr;16(2):633-42. doi: 10.1007/s00784-011-0550-y. Epub 2011 Mar 29.