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Clinical Trials/NCT05910424
NCT05910424CompletedNot Applicable

Characterisation of the Oral Microbiota and Oral Status of a Population of Adult Patients With Autism Spectrum Disorders: a Pilot Study

Central Hospital, Nancy, France2 sites in 1 country37 target enrollmentStarted: November 22, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
37
Locations
2
Primary Endpoint
Presence of periodontopathogenic bacteria (harmful for gums)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Masking Description

No Treatment

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • •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)
  • •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)

Outcomes

Primary Outcomes

Presence of periodontopathogenic bacteria (harmful for gums)

Time Frame: Collection on Day 1

Technique used = Polymerase Chain Reaction (PCR) Measure unit = Colony-Forming Unit (CFU)

Secondary Outcomes

  • Assessment of the periodontal status of patients with Autism Spectrum Disorder(Day 1)
  • Assessment of the presence of parasites Entamoeba gingivalis subtype 1 (ST1) and subtype 2 (ST2) and Trichomonas tenax(Collection on Day 1)
  • Assessment of the dental condition(Day 1)
  • Collection of data about lifestyle habits (oral and dental hygiene, diet, activity, etc.) and drug treatments that may influence the clinical parameters observed(Before samples collection and clinical examination)
  • Assessment of oral hygiene(Day 1)

Investigators

Sponsor
Central Hospital, Nancy, France
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

BERBE Ludivine

Dentist, University Hospital Assistant

Central Hospital, Nancy, France

Study Sites (2)

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Oral Microbiota and Oral Status of Adult... | Clinical Trial