Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients

Conditions
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Oral Health, Parkinson Disease

Intervention / Treatment
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* Behavioral: Delivery of oral hygiene advices


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parkinson's Patients<br> | Behavioral: Delivery of oral hygiene advices<br>* Patients will benefit from hygiene advice and maintenance of good oral health. No treatment will be administered as part of this study. Patients will continue their usual treatment according to the contraindications. Patients will benefit from salivary sampling and a collection of oral bacteria contained in the dental plaque using paper tips. These reviews will be conducted during the Inclusion Visit and the 6 month Follow-Up Visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decayed Missing Filled (DMF) index score | Min value : 0 (good oral health), Max value : 32 | 6 months after inclusion | 
| Presence of cariogenic bacteria in saliva and dental film | Streptococcus mutans and Lactobacillus | 6 months after inclusion | 
| Presence of periodontopathogenic bacteria in saliva and dental film | Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus | 6 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decayed Missing Filled (DMF) index score | Min value : 0 (good oral health), Max value : 32 | Inclusion visit (Day 0) | 
| Presence of cariogenic bacteria in saliva and dental film | Streptococcus mutans and Lactobacillus | Inclusion visit (Day 0) | 
| Presence of periodontopathogenic bacteria in saliva and dental film | Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus | Inclusion visit (Day 0) | 
| Change of Oral Health Impact Profile-14 (OHIP-14) | Min value : 14, Max value : 70 (satisfactory oral health) | Inclusion Visit (Day 0) and 6 month after | 
| Change of Geriatric/General Oral Health Assessment Index (GOHAI) | Min value : 12, Max value : 60 (satisfactory oral health) | Inclusion Visit (Day 0) and 6 month after | 
| Saliva pH | Normal / Acid / Very acid | Inclusion Visit (Day 0) and 6 month after | 
| Quantification of saliva flow | Normal / Low | Inclusion Visit (Day 0) and 6 month after | 
| Change of Community Periodontal Index of Treatment Needs (CPITN) | CPI Min value : 0 (healthy periodontium), Max value : 4 ; TN Min value : 0 (No periodontal treatment needed), Max value : 3 | Inclusion Visit (Day 0) and 6 month after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Health, Parkinson Disease, Tooth cavities, Saliva, Mucosa