Dental CaresPhase 3NCT00643838
Use of 50% Nitrous Oxide / 50% Oxygen Premix in Primary Care Dental Centers
A Phase 3 study testing Kalinox 170 bar in people with Dental Cares, run by Air Liquide Santé International at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Dental Cares
- What is being tested?
- Kalinox 170 bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 549 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2007to Jul 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
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers
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.
- Conditions
- Dental Cares
- Being tested
- Kalinox 170 bar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kalinox 170 barDrug
Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Misture of 50% nitrous oxide and 50% oxygen Receives: Drug: Kalinox 170 bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)
Measured: At the end of the dental care
Secondary outcomes (1)
Patient's acceptance and doctor's satisfaction
Measured: At the end of dental care
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 startDec 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental CaresStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643838
- Sponsor's protocol ID
- EudraCT : 2006-005691-40
- Status last verified
- Jan 2009
- First submitted
- 20 Mar 2008
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Hennequin M, Collado V, Faulks D, Koscielny S, Onody P, Nicolas E. A clinical trial of efficacy and safety of inhalation sedation with a 50% nitrous oxide/oxygen premix (Kalinox) in general practice. Clin Oral Investig. 2012 Apr;16(2):633-42. doi: 10.1007/s00784-011-0550-y. Epub 2011 Mar 29.
PubMed 22186944
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers
- ClinicalTrials.gov ID
- NCT00643838
- Acronym / sponsor ID
- EudraCT : 2006-005691-40
- Conditions
- Dental Cares
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Kalinox 170 barMisture of 50% nitrous oxide and 50% oxygen |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Kalinox 170 barFlow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour | Drug | A |
Primary outcome
Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)
Time frame: At the end of the dental care
1 secondary outcome
Patient's acceptance and doctor's satisfaction
Time frame: At the end of dental care
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Results publication: PubMed 22186944Hennequin M, Collado V, Faulks D, Koscielny S, Onody P, Nicolas E. A clinical trial of efficacy and safety of inhalation sedation with a 50% nitrous oxide/oxygen premix (Kalinox) in general practice. Clin Oral Investig. 2012 Apr;16(2):633-42. doi: 10.1007/s00784-011-0550-y. Epub 2011 Mar 29.
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 Kalinox 170 bar in people with Dental Cares, 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 15 Sep 2025. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS) (time frame: At the end of the dental care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00643838, which also lists 1 linked publication.
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 15 Sep 2025.