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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

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

Condition or disease Intervention/treatment Phase
Oral Health Parkinson Disease Behavioral: Delivery of oral hygiene advices Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Decayed Missing Filled (DMF) index score [ Time Frame: 6 months after inclusion ]
    Min value : 0 (good oral health), Max value : 32

  2. Presence of cariogenic bacteria in saliva and dental film [ Time Frame: 6 months after inclusion ]
    Streptococcus mutans and Lactobacillus

  3. 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 Outcome Measures :
  1. Decayed Missing Filled (DMF) index score [ Time Frame: Inclusion visit (Day 0) ]
    Min value : 0 (good oral health), Max value : 32

  2. Presence of cariogenic bacteria in saliva and dental film [ Time Frame: Inclusion visit (Day 0) ]
    Streptococcus mutans and Lactobacillus

  3. 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

  4. 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)

  5. 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)

  6. Saliva pH [ Time Frame: Inclusion Visit (Day 0) and 6 month after ]
    Normal / Acid / Very acid

  7. Saliva flow [ Time Frame: Inclusion Visit (Day 0) and 6 month after ]
    Normal / Low

  8. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827551


Contacts
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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

Locations
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France
CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33076
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   
Principal Investigator: Johan SAMOT, DDS-PhD         
Sub-Investigator: Cécile BADET, DDS-PhD         
Sub-Investigator: Bruno ELLA NGUEMA, DDS-PhD         
Sub-Investigator: Dominique GUELH, MD-PhD         
Sub-Investigator: Pierre BURBAUD, MD-PhD         
Sub-Investigator: Nathalie DAMON-PERRIERE, MD-PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
Capionis
France Parkinson Association

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03827551     History of Changes
Other Study ID Numbers: CHUBX 2018/44
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Oral Health
Parkinson Disease
Tooth cavities
Saliva
Mucosa

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases