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

Not Applicable

Completed

• Conditions: Oral Health; Parkinson Disease
• Interventions: Behavioral: Delivery of oral hygiene advices

• Registration Number: NCT03827551
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Study Start: 2019-04-29
• Primary Completion: 2021-04-06
• Study Completion: 2021-04-06
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Parkinson's Patients	Delivery of oral hygiene advices	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France