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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

549 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dental Cares

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Misture of 50% nitrous oxide and 50% oxygen

Group Type EXPERIMENTAL

Kalinox 170 bar

Intervention Type DRUG

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

Interventions

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Kalinox 170 bar

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No