NCT03453411

Brief Summary

The main objective of this project is to evaluate the effects sought and the effects felt by children when EMONO is used in pediatric dental care. The Investigators will try to characterize the children who have submitted a request to extend contact with EMONO. The maintenance of a framework for the safe use of this drug whose place in dental care is fundamental and the benefit ratio is very favorable is essential.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
679

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2020

Completed
Last Updated

March 25, 2021

Status Verified

February 1, 2018

Enrollment Period

2.1 years

First QC Date

February 26, 2018

Last Update Submit

March 24, 2021

Conditions

Dental Care

Keywords

Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO)Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

  • Description of the effects felt and sought after by EMONO during the first care session.

    Exhaustive interview of patients about the presence or absence of each expected effect of EMONO and each adverse event at the first session of care; with also questioning the perception of this effect (positive or not).

    Day 0

Secondary Outcomes (5)

  • Assess the child's appreciation of the EMONO

    Day 0

  • Characterization of children who experience both analgesia and anxietyolysis

    Day 0

  • Evaluate children's palatability for EMONO and characterize children with high palatability.

    Day 0

  • Evaluate the course of taking EMONO between the first and the last session of care

    Month 1

  • Assess the impact of the difference in practice between the French University Hospitals on anxiety

    Day 0

Study Arms (1)

Non interventional study

Other: Non interventional study

Interventions

Non interventional studyOTHER

Non interventional study

Non interventional study

Eligibility Criteria

Age3 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

For this study we have therefore chosen to include all patients under 15 years of age seen for care under EMONO in the different participating DSCs. The use of EMONO in dental care is indicated for minor patients who are not cooperating in the dental care (doing not allow the realisation in the chair of care according to the acquired data of science) or who have a handicap limiting their cooperation. It applies during diagnostic or therapeutic consultations. The investigators will not include patients under 3 years of age as EMONO is much less effective below this age. All dental surgeons of the participating DSCs will be responsible for selecting patients who meet the inclusion criteria, offering selected patients and their parents to participate and include them in the study.

You may qualify if:

  • Children aged 3 to 15, requiring care under MEOPA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Nantes

Nantes, 44093, France

Location

Related Publications (2)

  • Prud'homme T, Rousselet M, Istvan M, Cheraud-Carpentier M, Dajean-Trutaud S, Lopez S, Muller-Bolla M, Marty M; French Pediatric Dentistry Network (FPDN); Feuillet F, Victorri-Vigneau C. Equimolar oxygen-nitrous oxide (EMONO) in dental pediatric care: which patients achieve therapeutic effects? A French national exploratory prospective observational multicenter study. Eur Arch Paediatr Dent. 2025 Feb;26(1):149-158. doi: 10.1007/s40368-024-00950-2. Epub 2024 Nov 15.

    PMID: 39548019DERIVED

  • Prud'homme T, Dajean-Trutaud S, Rousselet M, Feuillet F, Carpentier-Cheraud M, Bonnot O, Hyon I, Grall-Bronnec M, Lopez-Cazaux S, Victorri-Vigneau C. The MEOPAeDent trial protocol-an observational study of the Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) effects in paediatric dentistry. BMC Oral Health. 2019 Mar 7;19(1):42. doi: 10.1186/s12903-019-0732-6.

    PMID: 30845960DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

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

February 26, 2018

First Posted

March 5, 2018

Study Start

May 17, 2018

Primary Completion

June 24, 2020

Study Completion

June 24, 2020

Last Updated

March 25, 2021

Record last verified: 2018-02

Locations

FR(1)