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

NCT ID: NCT03827551

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-29
• Study Completion Date: 2021-04-06

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.

Conditions

Oral Health; Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Parkinson's Patients

Group Type: EXPERIMENTAL

Delivery of oral hygiene advices

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capionis

UNKNOWN

Sponsor Role: collaborator

France Parkinson Association

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

References

Donnet L, Claisse O, Samot J. Serotype and distribution of adhesion genes in Streptococcus mutans isolated from people with Parkinson's disease. Odontology. 2025 Oct;113(4):1520-1532. doi: 10.1007/s10266-025-01078-5. Epub 2025 Mar 6.

Reference Type: DERIVED

PMID: 40048130 (View on PubMed)

Other Identifiers

CHUBX 2018/44

Identifier Type: -

Identifier Source: org_study_id