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

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05910424

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Other: collection of saliva, gum fluid and/or dental plaque samples	N/A

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

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pilot study concerning adults with autism spectrum disorderPilot study concerning adults with autism spectrum disorder

Masking:

None (Open Label)

Masking Description:

No Treatment

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: 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

Arm

Intervention/Treatment

Experimental: 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

Other: 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

Outcome Measures

Primary Outcome Measures

Presence of periodontopathogenic bacteria (harmful for gums) [Collection on Day 1]
Technique used = Polymerase Chain Reaction (PCR) Measure unit = Colony-Forming Unit (CFU)

Secondary Outcome Measures

Assessment of the presence of parasites Entamoeba gingivalis subtype 1 (ST1) and subtype 2 (ST2) and Trichomonas tenax [Collection on Day 1]
Technique = Polymerase Chain Reaction (PCR) Unit = Colony-Forming Unit (CFU)
Assessment of the periodontal status of patients with Autism Spectrum Disorder [Day 1]
Index used = the Dutch Periodontal Index 0 = minimum value, better outcome 4 = maximum value, worse outcome
Assessment of the dental condition [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
Assessment of oral hygiene [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
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]
Data collection via a form fulfilled by the participant or the patient's legal guardian

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)