Multicenter Prospective Longitudinal Study on the Efficacy of Exclusive Odontological and Medical Treatment in the Management of Chronic Dental Maxillary Sinusitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Number of therapeutic successes
研究概览
简要总结
The study will be offered to patients for whom chronic maxillary sinusitis will be diagnosed in the first ENT (ear, nose and throat) consultation. These patients will then be seen in a stomatology consultation to determine whether or not a dental cause is objective
详细描述
Chronic maxillary sinusitis is an inflammatory condition and/or infectious diseases of the maxillary sinus, which last longer than 12 weeks. Those whose the origin is dental, are well described, and yet under-diagnosed most of the time due to a lack of well-defined diagnostic criteria and literature. There is controversy in the various studies about their prevalence. Their management and in particular the therapeutic sequence, is not the subject of any recommendation and involves only a few clinical studies. Their consequences on the patient's general health and quality of life are important. The lack of knowledge about them often leads to diagnostic errors and therefore to a persistence of symptomatology. Moreover, their complications when they are not or incorrectly treated, although rare, can be dramatic (occulo-orbital or endo-cranial complications for example).
Preliminary work in the form of a retrospective study was carried out within of the Centre Hospitalier intercommunal de Créteil in 2015. In view of the results the investigators wanted to set up a clinical trial with the following objectives measure the prevalence of chronic maxillary sinusitis of dental origin and measure the effectiveness of exclusive dental and medical treatment, which could avoid surgical intervention under general anaesthesia, at the higher morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age ≥ 18 years old
- •Signed Informed Consent
- •Patient with chronic maxillary sinusitis diagnosed by examination of the patient and ENT examination by naso-fibroscopy
- •Sinus imaging to confirm the diagnosis (facial mass scanner or cone beam CT)
- •Affiliated or beneficiary of a social security scheme
排除标准
- •Fungal bullet sinusitis
- •Naso-sinus polyposis
- •atelectasic sinusitis
- •Systemic damage that may affect the maxillary sinuses (muciviscidosis, primary ciliary dyskinesia, vasculitis, granulomatosis, history of radiotherapy of the facial mass, pregnancy)
- •Long-term immunosuppressive treatment (chemo, anti-rejection)
- •Rhinosinusian tumor process
- •Fronto-ethmoidomaxillary sinusitis with risk of orbital or meningeal damage in the short to medium term.
- •Refusal of consent
- •Simultaneous participation in another intervention research
- •Patient under guardianship, curatorship or justice protection
结局指标
主要结局
Number of therapeutic successes
时间窗: 3 months after the end of dental care
Disappearance of symptoms and absence of pus from the meatus observed at the 2nd consultation visit ENT control
次要结局
- Percentage of patients with preserved teeth(3 months after the end of dental care)
- Number of dental origin(3 months after the end of dental care)
- Percentage of each type of dental disease causing chronic maxillary sinusitis(3 months after the end of dental care)