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Breathing easy at the dentist: new gas calms nerves and pain

NCT ID NCT00643838

Symptom relief Sponsor: Air Liquide Santé International Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a gas called Kalinox, a mix of nitrous oxide and oxygen, to help patients relax during dental care. It included 549 anxious or phobic patients, young children, and mentally disabled adults across 36 French dental centers. The goal was to see if the gas reduces pain and makes dental visits easier for both patients and dentists.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Kalinox (50% nitrous oxide / 50% oxygen premix)
What this could lead to
If successful, this could provide a safe and effective sedation option for anxious dental patients, reducing pain and fear during procedures.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The gas mix may not work for all patients, and side effects like dizziness or nausea are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

549 people

The number who actually took part.

Start date

Dec 2007

Finished

Jul 2008

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

dental caries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dental cares

Contacts and locations

Locations

  • Primary dental care centers

    Clermont-Ferrand, France