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

Air Liquide

Status and phase: Terminated; Phase 3

Conditions: Dental Cares Under Kalinox's Inhalation

Treatments: Drug: Air Médical; Drug: Oxygène

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643786

EudraCT : 031003

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 1+ year old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Oxygène

Treatment:

Drug: Oxygène

B

Placebo Comparator group

Description:

Air Médical

Treatment:

Drug: Air Médical