Dental Carie; OrthodonticsNCT02909816
Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients
An observational study of Dental Carie; Orthodontics, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric Dental Patients. The investigators performed a multicenter observational study. The investigators included patients aged 1 to 18 years and who have already failed dental care because of non-cooperation; they could be with mental… Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Carie; Orthodontics
- How many people
- 364 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Apr 2018
- Phase
- Observational
- 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 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: * Patients under 18 years * Patients who have already failed dental care because of non-cooperation * Patients with or without mental or cognitive disabilities (regardless of type) * Patients with or without sedative premedication
Who may be able to join
- Patients under 18 years
- Use of nitrous oxide/oxygen analgesia/anxiolysis
- Any type of dental care
Who cannot join
- Use of midazolam
- Use of general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric Dental Patients. The investigators performed a multicenter observational study. The investigators included patients aged 1 to 18 years and who have already failed dental care because of non-cooperation; they could be with mental or cognitive disabilities and could have sedative premedication. The investigators performed any type of dental care With the Use of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after dental care.
- Conditions
- Dental Carie; Orthodontics
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of vomiting
Measured: from the beginning of Nitrous Oxide/Oxygen administration up to half an hour after the end of dental treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startApr 2015
- Primary completionSep 2016
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Carie; OrthodonticsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frederic COURSON, Assistance Publique - Hôpitaux de Paris
- Investigators
- Violaine Smaïl-Faugeron, PhD, DDS, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909816
- Sponsor's protocol ID
- MEOPA
- Status last verified
- Apr 2018
- First submitted
- 9 Sep 2016
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients
- ClinicalTrials.gov ID
- NCT02909816
- Acronym / sponsor ID
- MEOPA
- Conditions
- Dental Carie; Orthodontics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 21 Sep 2016 (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 objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric Dental Patients. The investigators performed a multicenter observational study. The investigators included patients aged 1 to 18 years and who have already failed dental care because of non-cooperation; they could be with mental or cognitive disabilities and could have sedative premedication. The investigators performed any type of dental care With the Use of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after dental care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- * Patients under 18 years * Patients who have already failed dental care because of non-cooperation * Patients with or without mental or cognitive disabilities (regardless of type) * Patients with or without sedative premedication
Key inclusion criteria (3 listed)
- Patients under 18 years
- Use of nitrous oxide/oxygen analgesia/anxiolysis
- Any type of dental care
Key exclusion criteria (2 listed)
- Use of midazolam
- Use of general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of vomiting
Time frame: from the beginning of Nitrous Oxide/Oxygen administration up to half an hour after the end of dental treatment
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 20 Apr 2018.
- Individual participant dataSharing planned: No
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.
Violaine Smaïl-Faugeron, PhD, DDS principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Carie; Orthodontics, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 2 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 20 Apr 2018. 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.
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?
occurrence of vomiting (time frame: from the beginning of Nitrous Oxide/Oxygen administration up to half an hour after the end of dental treatment). 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 20 Apr 2018.