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

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ClinicalTrials.gov Identifier: NCT03827551
Recruitment Status : Not yet recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
Capionis
France Parkinson Association
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE January 25, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date February 1, 2019
Estimated Study Start Date  ICMJE February 2019
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Decayed Missing Filled (DMF) index score [ Time Frame: 6 months after inclusion ]
    Min value : 0 (good oral health), Max value : 32
  • Presence of cariogenic bacteria in saliva and dental film [ Time Frame: 6 months after inclusion ]
    Streptococcus mutans and Lactobacillus
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Decayed Missing Filled (DMF) index score [ Time Frame: Inclusion visit (Day 0) ]
    Min value : 0 (good oral health), Max value : 32
  • Presence of cariogenic bacteria in saliva and dental film [ Time Frame: Inclusion visit (Day 0) ]
    Streptococcus mutans and Lactobacillus
  • Presence of periodontopathogenic bacteria in saliva and dental film [ Time Frame: Inclusion visit (Day 0) ]
    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) [ Time Frame: Inclusion Visit (Day 0) and 6 month after ]
    Min value : 14, Max value : 70 (satisfactory oral health)
  • Change of Geriatric/General Oral Health Assessment Index (GOHAI) [ Time Frame: Inclusion Visit (Day 0) and 6 month after ]
    Min value : 12, Max value : 60 (satisfactory oral health)
  • Saliva pH [ Time Frame: Inclusion Visit (Day 0) and 6 month after ]
    Normal / Acid / Very acid
  • Saliva flow [ Time Frame: Inclusion Visit (Day 0) and 6 month after ]
    Normal / Low
  • Change of Community Periodontal Index of Treatment Needs (CPITN) [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients
Official Title  ICMJE Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Oral Health
  • Parkinson Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Parkinson's Patients
Intervention: Behavioral: Delivery of oral hygiene advices
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Johan SAMOT, DDS-PhD 05 56 79 48 50 ext +33 johan.samot@u-bordeaux.fr
Contact: Olivier BRANCHARD 05 57 82 06 97 ext +33 olivier.branchard@chu-bordeaux.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03827551
Other Study ID Numbers  ICMJE CHUBX 2018/44
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE
  • Capionis
  • France Parkinson Association
Investigators  ICMJE Not Provided
PRS Account University Hospital, Bordeaux
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP