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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03827551
Acronym
PARKIDENT
Enrollment
40
Registered
2019-02-01
Start date
2019-04-29
Completion date
2021-04-06
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Health, Parkinson Disease

Keywords

Oral Health, Parkinson Disease, Tooth cavities, Saliva, Mucosa

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.

Interventions

BEHAVIORALDelivery 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.

Sponsors

Capionis
CollaboratorUNKNOWN
France Parkinson Association
CollaboratorOTHER
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decayed Missing Filled (DMF) index score6 months after inclusionMin value : 0 (good oral health), Max value : 32
Presence of cariogenic bacteria in saliva and dental film6 months after inclusionStreptococcus mutans and Lactobacillus
Presence of periodontopathogenic bacteria in saliva and dental film6 months after inclusionAggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus

Secondary

MeasureTime frameDescription
Change of Oral Health Impact Profile-14 (OHIP-14)Inclusion Visit (Day 0) and 6 month afterMin value : 14, Max value : 70 (satisfactory oral health)
Change of Geriatric/General Oral Health Assessment Index (GOHAI)Inclusion Visit (Day 0) and 6 month afterMin value : 12, Max value : 60 (satisfactory oral health)
Decayed Missing Filled (DMF) index scoreInclusion visit (Day 0)Min value : 0 (good oral health), Max value : 32
Quantification of saliva flowInclusion Visit (Day 0) and 6 month afterNormal / Low
Change of Community Periodontal Index of Treatment Needs (CPITN)Inclusion Visit (Day 0) and 6 month afterCPI Min value : 0 (healthy periodontium), Max value : 4 ; TN Min value : 0 (No periodontal treatment needed), Max value : 3
Saliva pHInclusion Visit (Day 0) and 6 month afterNormal / Acid / Very acid
Presence of cariogenic bacteria in saliva and dental filmInclusion visit (Day 0)Streptococcus mutans and Lactobacillus
Presence of periodontopathogenic bacteria in saliva and dental filmInclusion visit (Day 0)Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 7, 2026