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

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Oral Health
• Intervention / Treatment: Behavioral: Delivery of oral hygiene advices

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Parkinson's Patients

Behavioral: Delivery of oral hygiene advices; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: France Parkinson Association; Capionis

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2019
• Primary Completion (Actual): April 6, 2021
• Study Completion (Actual): April 6, 2021

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 31, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Parkinson Disease; Oral Health; Saliva; Mucosa; Tooth cavities
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: CHUBX 2018/44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No