CompletedPhase 3

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

France549 participantsStarted 2007-12

Plain-language summary

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.

Who can participate

Age range

1 Year

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)

Timeframe: At the end of the dental care

Trial details

NCT IDNCT00643838

SponsorAir Liquide Santé International

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-07

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