Interest of Re-oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares

Validation of a Kalinox's Administration Protocol for Dental Cares : Interest of Re-oxygenation and Pollution Control

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00643786

Enrollment

128

Registered

2008-03-26

Start date

2004-02-29

Completion date

2008-06-30

Last updated

2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Cares Under Kalinox's Inhalation

Brief summary

The usefulness of re-oxygenation after inhalation of 50% nitrous oxide and 50% oxygen premix (Kalinox 170 bar) during dental care is studied and the pollution resulting from administration of Kalinox is also investigated.

Interventions

DRUGOxygène

Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation

DRUGAir Médical

Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Inclusion criteria

* From 1 year old * anxious or phobic patients * very young children requiring selective dental cares * mental deficient patients * ASA 1 or ASA 2 patients

Exclusion criteria

* ASA 3 or ASA 4 patients * contraindication linked to the experimental product * patients with mental disorder incompatible with the motory test * patients that have received anxiolytic treatment less than 2 hours before the dental care

Design outcomes

Primary

Measure	Time frame
Measurement of SpO2	In continuous

Secondary

Measure	Time frame
Analysis of ambient air pollution by nitrous oxide and patient's acceptance	In continuous

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026