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NCT00643838
Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers
Phase 3 trial testing Kalinox 170 bar in Dental Cares in 549 participants. Completed in 1 July 2008.
1 July 2008
Quick facts
| Lead sponsor | Air Liquide Santé International |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 549 |
| Start date | 1 December 2007 |
| Primary completion | 1 July 2008 |
| Estimated completion | 1 July 2008 |
| Sites | 1 location across France |
Drugs / interventions tested
- Kalinox 170 bar — full drug profile →
Conditions studied
- Dental Cares — all drugs for Dental Cares →
Sponsor
Air Liquide Santé International — full company profile →
Who can join
1 and older, any sex, with Dental Cares. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)
Time frame: At the end of the dental care
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00643838
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00643838 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Air Liquide Santé International
- Last refreshed: 9 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00643838.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing