Clinical trial NCT03827551: Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients
Official title: Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Health
Parkinson Disease
Keywords: Oral Health
Parkinson Disease
Tooth cavities
Saliva
Mucosa
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Capionis
name: France Parkinson Association
First posted: 2019-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a prospective interventional clinical study whose main objective is to determine the impact of oral hygiene guidance on the oral health status of patients with Parkinson disease

Detailed description: Caries and periodontitis are infectious diseases that can eventually lead to the loss of the dental organ. The masticatory deficit engendered will have repercussions on the general state of the subject and on his quality of life (pains, difficulties of feeding which can cause nutritional deficiencies ...). The systematic review of the literature, despite low levels of evidence, shows that there is an influence of Parkinson's disease on oral health. Our goal is therefore to determine the impact of implementing appropriate oral hygiene measures on improving the quality of life of patients with Parkinson's disease.

This is a 40-patient, interventional, preliminary study that will rely on indicators of oral health status (DMF, Periodontal Index, presence of pathogenic bacteria), as well as a questionnaire measuring impact of oral conditions on patient well-being (OHIP-14). These data will be collected before and after the implementation of the hygiene measures, within a period of 6 months.

Eligibility criteria: Inclusion Criteria:

* Major patient
* Patient with Parkinson disease
* Able to give written informed consent
* Affiliated to French health care system

Exclusion Criteria:

* Patient under tutorship and curatorship
* Pregnant women
* Patient wearing subtotal or total dental prosthesis
* Antibiotic treatment or antiseptic mouthwashes in the month prior to sampling
* Patient with less than 6 teeth distributed on maxilla and mandible

Primary outcomes:
measure: Decayed Missing Filled (DMF) index score
timeFrame: 6 months after inclusion
measure: Presence of cariogenic bacteria in saliva and dental film
timeFrame: 6 months after inclusion
measure: Presence of periodontopathogenic bacteria in saliva and dental film
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Decayed Missing Filled (DMF) index score
timeFrame: Inclusion visit (Day 0)
measure: Presence of cariogenic bacteria in saliva and dental film
timeFrame: Inclusion visit (Day 0)
measure: Presence of periodontopathogenic bacteria in saliva and dental film
timeFrame: Inclusion visit (Day 0)
measure: Change of Oral Health Impact Profile-14 (OHIP-14)
timeFrame: Inclusion Visit (Day 0) and 6 month after
measure: Change of Geriatric/General Oral Health Assessment Index (GOHAI)
timeFrame: Inclusion Visit (Day 0) and 6 month after
measure: Saliva pH
timeFrame: Inclusion Visit (Day 0) and 6 month after
measure: Quantification of saliva flow
timeFrame: Inclusion Visit (Day 0) and 6 month after
measure: Change of Community Periodontal Index of Treatment Needs (CPITN)
timeFrame: Inclusion Visit (Day 0) and 6 month after
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: