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

Air Liquide

Status and phase: Completed; Phase 3

Conditions: Dental Cares

Treatments: Drug: Kalinox 170 bar

Study type: Interventional

Funder types: Industry

Identifiers

NCT00643838

EudraCT : 2006-005691-40

Details and patient eligibility

About

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.

Enrollment: 549 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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549 participants in 1 patient group

A

Experimental group

Description:

Misture of 50% nitrous oxide and 50% oxygen

Treatment:

Drug: Kalinox 170 bar