NCT00643838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
549

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

September 15, 2025

Status Verified

January 1, 2009

Enrollment Period

7 months

First QC Date

March 20, 2008

Last Update Submit

September 9, 2025

Conditions

Dental Cares

Outcome Measures

Primary Outcomes (1)

  • Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)

    At the end of the dental care

Secondary Outcomes (1)

  • Patient's acceptance and doctor's satisfaction

    At the end of dental care

Study Arms (1)

A

EXPERIMENTAL

Misture of 50% nitrous oxide and 50% oxygen

Drug: Kalinox 170 bar

Interventions

Kalinox 170 barDRUG

Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour

A

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary dental care centers

Clermont-Ferrand, France

Location

Related Publications (1)

  • 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.

    PMID: 22186944RESULT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

December 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

September 15, 2025

Record last verified: 2009-01

Locations

FR(1)