Use of 50% Nitrous Oxide / 50% Oxygen Premix in Primary Care Dental Centers
Phase 3
Completed
- Conditions
- Dental Cares
- Interventions
- Drug: Kalinox 170 bar
- Registration Number
- NCT00643838
- Lead Sponsor
- Air Liquide Santé International
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A Kalinox 170 bar Misture of 50% nitrous oxide and 50% oxygen
- Primary Outcome Measures
Name Time Method Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS) At the end of the dental care
- Secondary Outcome Measures
Name Time Method Patient's acceptance and doctor's satisfaction At the end of dental care
Trial Locations
- Locations (1)
Primary dental care centers
🇫🇷France, France