Dental Cares Under Kalinox's InhalationPhase 3NCT00643786
Interest of Re-oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares
A Phase 3 study testing Oxygène and Air Médical in people with Dental Cares Under Kalinox's Inhalation, run by Air Liquide Santé International at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Dental Cares Under Kalinox's Inhalation
- What is being tested?
- Oxygène and Air Médical
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2004to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- From 1 year old
- anxious or phobic patients
- very young children requiring selective dental cares
- mental deficient patients
- ASA 1 or ASA 2 patients
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Kalinox's Administration Protocol for Dental Cares : Interest of Re-oxygenation and Pollution Control
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.
- Conditions
- Dental Cares Under Kalinox's Inhalation
- Being tested
- Oxygène, Air Médical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygèneDrug
Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation
Air MédicalDrug
Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Oxygène Receives: Drug: Oxygène |
| B | Placebo comparator | Air Médical Receives: Drug: Air Médical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of SpO2
Measured: In continuous
Secondary outcomes (1)
Analysis of ambient air pollution by nitrous oxide and patient's acceptance
Measured: In continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startFeb 2004
- Primary completionMay 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Cares Under Kalinox's InhalationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643786
- Sponsor's protocol ID
- EudraCT : 031003
- Status last verified
- Jun 2014
- First submitted
- 20 Mar 2008
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Kalinox's Administration Protocol for Dental Cares : Interest of Re-oxygenation and Pollution Control
- ClinicalTrials.gov ID
- NCT00643786
- Acronym / sponsor ID
- EudraCT : 031003
- Conditions
- Dental Cares Under Kalinox's Inhalation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 26 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: OxygèneOxygène |
| B | Placebo comparator | Drug: Air MédicalAir Médical |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- From 1 year old
- anxious or phobic patients
- very young children requiring selective dental cares
- mental deficient patients
- ASA 1 or ASA 2 patients
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygèneFlow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation | Drug | A |
| Air MédicalFlow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation | Drug | B |
Primary outcome
Measurement of SpO2
Time frame: In continuous
1 secondary outcome
Analysis of ambient air pollution by nitrous oxide and patient's acceptance
Time frame: In continuous
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxygène and Air Médical in people with Dental Cares Under Kalinox's Inhalation, run by Air Liquide Santé International at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of SpO2 (time frame: In continuous). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.