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Clinical Trials/NCT03827551
NCT03827551
Completed
Not Applicable

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

University Hospital, Bordeaux1 site in 1 country40 target enrollmentApril 29, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oral Health
Sponsor
University Hospital, Bordeaux
Enrollment
40
Locations
1
Primary Endpoint
Presence of cariogenic bacteria in saliva and dental film
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 29, 2019
End Date
April 6, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Presence of cariogenic bacteria in saliva and dental film

Time Frame: 6 months after inclusion

Streptococcus mutans and Lactobacillus

Decayed Missing Filled (DMF) index score

Time Frame: 6 months after inclusion

Min value : 0 (good oral health), Max value : 32

Presence of periodontopathogenic bacteria in saliva and dental film

Time Frame: 6 months after inclusion

Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus

Secondary Outcomes

  • Decayed Missing Filled (DMF) index score(Inclusion visit (Day 0))
  • Change of Geriatric/General Oral Health Assessment Index (GOHAI)(Inclusion Visit (Day 0) and 6 month after)
  • Change of Oral Health Impact Profile-14 (OHIP-14)(Inclusion Visit (Day 0) and 6 month after)
  • Saliva pH(Inclusion Visit (Day 0) and 6 month after)
  • Quantification of saliva flow(Inclusion Visit (Day 0) and 6 month after)
  • Presence of cariogenic bacteria in saliva and dental film(Inclusion visit (Day 0))
  • Presence of periodontopathogenic bacteria in saliva and dental film(Inclusion visit (Day 0))
  • Change of Community Periodontal Index of Treatment Needs (CPITN)(Inclusion Visit (Day 0) and 6 month after)

Study Sites (1)

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