Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care

Periodontal Disease Clinical Trial

— MEOPAeDent  

Official title:

Uncontrolled Prospective Single-center Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894463
• Other study ID #: RC14_0213
• Status: Completed
• Phase: N/A
• First received: August 11, 2016
• Last updated: September 8, 2016
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2016
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases

Intervention

Other:
• questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline	No