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Oral Health Assessment of Children in CP Class

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04795258
Recruitment Status : Completed
First Posted : March 12, 2021
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:
Few oral exams are performed on 6-year-olds (key age for carious disease). This project aims to increase the number of oral check-ups for 6-year-olds in fragile areas (REP/REP+ areas).

Condition or disease
Dental Caries

Study Design
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Study Type : Observational
Actual Enrollment : 671 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oral Health Assessment of Children in CP Class in REP/REP+ Areas in the Department of Hérault
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : January 30, 2021
Actual Study Completion Date : March 1, 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Presence of decay on each tooth present in the mouth [ Time Frame: 1 day ]
    Presence of decay on each tooth present in the mouth

  2. Presence of care on each tooth present in the mouth [ Time Frame: 1 day ]
    Presence of care on each tooth present in the mouth


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
first-grade student enrolled in a school in a zone REP/REP+
Criteria

Inclusion criteria:

  • Be a first-grade student enrolled in a school in a zone REP/REP+
  • Have a parental permission
  • Good understanding of the French language

Exclusion criteria:

- lack of parental permission

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04795258


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Camille INQUIMBERT, PhD University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04795258    
Other Study ID Numbers: RECHMPL21_0116
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: NC

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Oral hygiene
Public Health
Children
Prevention
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases