NCT03827551

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 29, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2021

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

January 25, 2019

Last Update Submit

September 27, 2021

Conditions

Oral HealthParkinson Disease

Keywords

Oral HealthParkinson DiseaseTooth cavitiesSalivaMucosa

Outcome Measures

Primary Outcomes (3)

  • Decayed Missing Filled (DMF) index score

    Min value : 0 (good oral health), Max value : 32

    6 months after inclusion

  • Presence of cariogenic bacteria in saliva and dental film

    Streptococcus mutans and Lactobacillus

    6 months after inclusion

  • 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 Outcomes (8)

  • Decayed Missing Filled (DMF) index score

    Inclusion visit (Day 0)

  • Presence of cariogenic bacteria in saliva and dental film

    Inclusion visit (Day 0)

  • Presence of periodontopathogenic bacteria in saliva and dental film

    Inclusion visit (Day 0)

  • Change of Oral Health Impact Profile-14 (OHIP-14)

    Inclusion Visit (Day 0) and 6 month after

  • Change of Geriatric/General Oral Health Assessment Index (GOHAI)

    Inclusion Visit (Day 0) and 6 month after

  • +3 more secondary outcomes

Study Arms (1)

Parkinson's Patients

EXPERIMENTAL
Behavioral: Delivery of oral hygiene advices

Interventions

Delivery of oral hygiene advicesBEHAVIORAL

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.

Parkinson's Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major patient
  • Patient with Parkinson disease
  • Able to give written informed consent
  • Affiliated to French health care system

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33076, France

Location

Related Publications (1)

  • 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.

    PMID: 40048130DERIVED

MeSH Terms

Conditions

Parkinson DiseaseDental Caries

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 1, 2019

Study Start

April 29, 2019

Primary Completion

April 6, 2021

Study Completion

April 6, 2021

Last Updated

September 28, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)