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

Parkinson Disease Clinical Trial

— PARKIDENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03827551
• Other study ID #: CHUBX 2018/44
• Status: Completed
• Phase: N/A
• Start date: April 29, 2019
• Est. completion date: April 6, 2021

Study information

• Verified date: September 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 6, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oral Health
• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Capionis, France Parkinson Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decayed Missing Filled (DMF) index score	Min value : 0 (good oral health), Max value : 32	6 months after inclusion
Primary	Presence of cariogenic bacteria in saliva and dental film	Streptococcus mutans and Lactobacillus	6 months after inclusion
Primary	Presence of periodontopathogenic bacteria in saliva and dental film	Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus	6 months after inclusion
Secondary	Decayed Missing Filled (DMF) index score	Min value : 0 (good oral health), Max value : 32	Inclusion visit (Day 0)
Secondary	Presence of cariogenic bacteria in saliva and dental film	Streptococcus mutans and Lactobacillus	Inclusion visit (Day 0)
Secondary	Presence of periodontopathogenic bacteria in saliva and dental film	Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus	Inclusion visit (Day 0)
Secondary	Change of Oral Health Impact Profile-14 (OHIP-14)	Min value : 14, Max value : 70 (satisfactory oral health)	Inclusion Visit (Day 0) and 6 month after
Secondary	Change of Geriatric/General Oral Health Assessment Index (GOHAI)	Min value : 12, Max value : 60 (satisfactory oral health)	Inclusion Visit (Day 0) and 6 month after
Secondary	Saliva pH	Normal / Acid / Very acid	Inclusion Visit (Day 0) and 6 month after
Secondary	Quantification of saliva flow	Normal / Low	Inclusion Visit (Day 0) and 6 month after
Secondary	Change of Community Periodontal Index of Treatment Needs (CPITN)	CPI Min value : 0 (healthy periodontium), Max value : 4 ; TN Min value : 0 (No periodontal treatment needed), Max value : 3	Inclusion Visit (Day 0) and 6 month after