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

NCT02894463 | Completed

• 1 other identifier: RC14_0213
• Study Type: observational
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Periodontal Disease

Keywords

dental care; emeno; abuse

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

questionnaire OTHER

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Tony Prud'homme, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 9, 2016
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: September 9, 2016

Record last verified: 2016-08