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

Primary Purpose

Oral Health, Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Delivery of oral hygiene advices
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Oral Health focused on measuring Oral Health, Parkinson Disease, Tooth cavities, Saliva, Mucosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Parkinson's Patients

Arm Description

Outcomes

Primary Outcome Measures

Decayed Missing Filled (DMF) index score
Min value : 0 (good oral health), Max value : 32
Presence of cariogenic bacteria in saliva and dental film
Streptococcus mutans and Lactobacillus
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

Secondary Outcome Measures

Decayed Missing Filled (DMF) index score
Min value : 0 (good oral health), Max value : 32
Presence of cariogenic bacteria in saliva and dental film
Streptococcus mutans and Lactobacillus
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
Change of Oral Health Impact Profile-14 (OHIP-14)
Min value : 14, Max value : 70 (satisfactory oral health)
Change of Geriatric/General Oral Health Assessment Index (GOHAI)
Min value : 12, Max value : 60 (satisfactory oral health)
Saliva pH
Normal / Acid / Very acid
Quantification of saliva flow
Normal / Low
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

Full Information

First Posted
January 25, 2019
Last Updated
September 27, 2021
Sponsor
University Hospital, Bordeaux
Collaborators
Capionis, France Parkinson Association
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1. Study Identification

Unique Protocol Identification Number
NCT03827551
Brief Title
Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients
Acronym
PARKIDENT
Official Title
Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
April 6, 2021 (Actual)
Study Completion Date
April 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Capionis, France Parkinson Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Health, Parkinson Disease
Keywords
Oral Health, Parkinson Disease, Tooth cavities, Saliva, Mucosa

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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