Preliminary Study of the Quality of the Oral Flora in Parkinson's Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Presence of cariogenic bacteria in saliva and dental film
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major patient
- •Patient with Parkinson disease
- •Able to give written informed consent
- •Affiliated to French health care system
排除标准
- •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
结局指标
主要结局
Presence of cariogenic bacteria in saliva and dental film
时间窗: 6 months after inclusion
Streptococcus mutans and Lactobacillus
Decayed Missing Filled (DMF) index score
时间窗: 6 months after inclusion
Min value : 0 (good oral health), Max value : 32
Presence of periodontopathogenic bacteria in saliva and dental film
时间窗: 6 months after inclusion
Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Peptostreptococcus micros, Eikenella corrodens, Campylobacter rectus
次要结局
- Decayed Missing Filled (DMF) index score(Inclusion visit (Day 0))
- Change of Geriatric/General Oral Health Assessment Index (GOHAI)(Inclusion Visit (Day 0) and 6 month after)
- Change of Oral Health Impact Profile-14 (OHIP-14)(Inclusion Visit (Day 0) and 6 month after)
- Saliva pH(Inclusion Visit (Day 0) and 6 month after)
- Quantification of saliva flow(Inclusion Visit (Day 0) and 6 month after)
- 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 Community Periodontal Index of Treatment Needs (CPITN)(Inclusion Visit (Day 0) and 6 month after)