Oral Microbiota and Oral Status of Adult Patients With Autism Spectrum Disorders (MICAA: MICrobiota Autism Adults)

NCT ID: NCT05910424

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-22

Study Completion Date

2024-04-30

Brief Summary

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The goals of this pilot study are to assess the presence of harmful germs for gums and to assess oral health in adults with autism spectrum disorder.

Detailed Description

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Participants or their tutors will fulfill a form with general health information and daily habits.

Investigators will :

* collect saliva, gum fluid and/ or dental plaque to characterise germs
* assess gum health and oral hygiene
* register decays, filled and missing teeth.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot study concerning adults with autism spectrum disorder
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

No Treatment

Study Groups

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Adults with Autism Spectrum Disorder

* Adults with autism spectrum disorder
* Aged between 18 and 60 years old
* Dental cares and follow-up in Nancy hospital

Group Type EXPERIMENTAL

collection of saliva, gum fluid and/or dental plaque samples

Intervention Type OTHER

Non-invasive sampling of dental plaque, crevicular fluid and/or saliva, using an examination probe, paper tips and saliva swabs

Interventions

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collection of saliva, gum fluid and/or dental plaque samples

Non-invasive sampling of dental plaque, crevicular fluid and/or saliva, using an examination probe, paper tips and saliva swabs

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A person (or legal representative) who has received full information about the organisation of the research and accept to participate and the use of his or her data.
* Adult with autism spectrum disorder, men or women aged between 18 and 60.
* Member of a social security scheme or beneficiary of a medical insurance

Exclusion Criteria

* Children under 18 with autism spectrum disorder
* Use of medication or situations that may affect the microbiota (use of antibiotics, probiotics, steroidal or non-steroidal anti-inflammatory drugs in the last 3 months, strict mouth breathing)
* Smoking
* Very lingual position of the teeth hindering clinical assessment of the periodontium
* Patients who have had periodontal treatment for less than 6 months
* Persons covered by articles L. 1121-5 to L. 1121-7 and L1122-2 of the French Public Health Code:
* Pregnant women, women in labour or breast-feeding mothers
* Persons deprived of their liberty by a judicial or administrative decision
* Persons unable to give their consent
* Person under psychiatric care by virtue of articles L. 3212-1 and L. 3213-1 of the Public Health Code
* Minor (not emancipated)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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BERBE Ludivine

Dentist, University Hospital Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ludivine BERBE

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

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CHRU Brabois

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2023-A01024-41

Identifier Type: -

Identifier Source: org_study_id

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