Periodontal DiseaseMEOPAeDentNCT02894463
Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care
An observational study of Periodontal Disease, run by Nantes University Hospital at 1 site in France.
Trial summary
The aim of this study is to evaluate the potential risk of abusive behavior for children in care using nitrous oxide for dental care. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Periodontal Disease
- What is being tested?
- questionnaire
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to May 2015
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: All patients seen in consultation EMENO and being younger than 15 years will be offered this study. This is a population of non-cooperative patients to dental care or with a disability limiting their cooperation. A quick questionnaire will be submitted in the consultations EMENO the SSC, the children after their parents' permission.
Who may be able to join
- Children aged 3 to 15 years
- Requiring dental care under MEOPA
- Not opposing, as well as his parents, his participation in the study
- Not having difficulties tracking (going on holiday, imminent change, remoteness, lack of motivation)
Who cannot join
- Excluded patients are those whose dental care can be made to the vigil state, or on the contrary, will present a number of important care, justifying general anesthesia.
- Also excluded will be children whose parents no longer have parental authority or whose parents are divorced or divorcing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uncontrolled Prospective Single-center Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care
The aim of this study is to evaluate the potential risk of abusive behavior for children in care using nitrous oxide for dental care.
Read the detailed description
The expected prospects are therefore maintaining surveillance around the MEOPA following his release from hospital reserves, but also to ensure that the MEOPA not an addictive potential in the context of its use in dentistry. The results of this study will in any case to secure its application for dental care.
- Conditions
- Periodontal Disease
- Being tested
- questionnaire
- Keywords
- dental care, emeno, abuse
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of clear signs that the child is trying to extend the contact MEOPA ( questionnaire )
hand gesture to keep the mask over the nose and / or mouth, verbalization of the desire to keep the mask over the nose and / or mouth, to extend the negotiation contac
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startNov 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tony Prud'homme, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894463
- Sponsor's protocol ID
- RC14_0213
- Acronym
- MEOPAeDent
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled Prospective Single-center Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care
- ClinicalTrials.gov ID
- NCT02894463
- Acronym / sponsor ID
- MEOPAeDent / RC14_0213
- Conditions
- Periodontal Disease
- Keywords
- dental care, emeno, abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 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 aim of this study is to evaluate the potential risk of abusive behavior for children in care using nitrous oxide for dental care.
Detailed description
The expected prospects are therefore maintaining surveillance around the MEOPA following his release from hospital reserves, but also to ensure that the MEOPA not an addictive potential in the context of its use in dentistry. The results of this study will in any case to secure its application for dental care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All patients seen in consultation EMENO and being younger than 15 years will be offered this study. This is a population of non-cooperative patients to dental care or with a disability limiting their cooperation. A quick questionnaire will be submitted in the consultations EMENO the SSC, the children after their parents' permission.
Key inclusion criteria (4 listed)
- Children aged 3 to 15 years
- Requiring dental care under MEOPA
- Not opposing, as well as his parents, his participation in the study
- Not having difficulties tracking (going on holiday, imminent change, remoteness, lack of motivation)
Key exclusion criteria (2 listed)
- Excluded patients are those whose dental care can be made to the vigil state, or on the contrary, will present a number of important care, justifying general anesthesia.
- Also excluded will be children whose parents no longer have parental authority or whose parents are divorced or divorcing.
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 |
|---|---|---|
| questionnaire | Other | – |
Primary outcome
presence of clear signs that the child is trying to extend the contact MEOPA ( questionnaire )
Time frame: Baseline
hand gesture to keep the mask over the nose and / or mouth, verbalization of the desire to keep the mask over the nose and / or mouth, to extend the negotiation contac
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 24 Jun 2026.
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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.
Tony Prud'homme, Dr principal investigator
Nantes University Hospital
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 Periodontal Disease, run by Nantes University Hospital 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 4 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 24 Jun 2026. 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?
presence of clear signs that the child is trying to extend the contact MEOPA ( questionnaire ) (time frame: Baseline). 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 24 Jun 2026.