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Completed

NCT Number: NCT03827551

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delivery of oral hygiene advices

Behavioral

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 outcomes

  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 outcomes

  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. Quantification of 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Capionis
  • France Parkinson Association

Registry information

Acronym: PARKIDENT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2019
Registry last updated
Sep 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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