Skip to main content
OpenTrials
Completed

NCT Number: NCT05910424

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU Brabois

Vandœuvre-lès-Nancy, 54500, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other

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

Primary outcomes

  1. 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

  1. Assessment of the presence of parasites Entamoeba gingivalis subtype 1 (ST1) and subtype 2 (ST2) and Trichomonas tenax

    Time frame: Collection on Day 1

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

  2. Assessment of the periodontal status of patients with Autism Spectrum Disorder

    Time frame: Day 1

    Index used = the Dutch Periodontal Index 0 = minimum value, better outcome 4 = maximum value, worse outcome

  3. Assessment of the dental condition

    Time frame: Day 1

    Dental data will be collected using the Decay-Missing-Filled/Teeth (DMFT) score 0 = minimum value, best outcome 28 = maximum value, worst outcome

  4. Assessment of oral hygiene

    Time frame: Day 1

    Oral hygiene will be assessed using the Silness and Löe plaque index and the lifestyle questionnaire 0 = minimum value, best outcome 3 = maximum value, worst outcome

  5. Collection of data about lifestyle habits (oral and dental hygiene, diet, activity, etc.) and drug treatments that may influence the clinical parameters observed

    Time frame: Before samples collection and clinical examination

    Data collection via a form fulfilled by the participant or the patient's legal guardian

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: MICAA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.