Dental Cares
Conditions
Brief 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.
Interventions
DRUGKalinox 170 bar
Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour
Sponsors
Air Liquide Santé International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS) | At the end of the dental care |
Secondary
| Measure | Time frame |
|---|---|
| Patient's acceptance and doctor's satisfaction | At the end of dental care |
Countries
France
Outcome results
None listed