Clinical trial NCT04085536: Prospective Study on the Efficacy of Exclusive Odontological and Medical Treatment in Chronic Dental Maxillary Sinusitis
Official title: Multicenter Prospective Longitudinal Study on the Efficacy of Exclusive Odontological and Medical Treatment in the Management of Chronic Dental Maxillary Sinusitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Maxillary Sinusitis
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2019-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. Signed Informed Consent
3. Patient with chronic maxillary sinusitis diagnosed by examination of the patient and ENT examination by naso-fibroscopy
4. Sinus imaging to confirm the diagnosis (facial mass scanner or cone beam CT)
5. Affiliated or beneficiary of a social security scheme

Exclusion Criteria:

1. Fungal bullet sinusitis
2. Naso-sinus polyposis
3. atelectasic sinusitis
4. Systemic damage that may affect the maxillary sinuses (muciviscidosis, primary ciliary dyskinesia, vasculitis, granulomatosis, history of radiotherapy of the facial mass, pregnancy)
5. Long-term immunosuppressive treatment (chemo, anti-rejection)
6. Rhinosinusian tumor process
7. Fronto-ethmoidomaxillary sinusitis with risk of orbital or meningeal damage in the short to medium term.
8. Refusal of consent
9. Simultaneous participation in another intervention research
10. Patient under guardianship, curatorship or justice protection

Primary outcomes:
measure: Number of therapeutic successes
timeFrame: 3 months after the end of dental care
Secondary outcomes:
measure: Number of dental origin
timeFrame: 3 months after the end of dental care
measure: Percentage of patients with preserved teeth
timeFrame: 3 months after the end of dental care
measure: Percentage of each type of dental disease causing chronic maxillary sinusitis
timeFrame: 3 months after the end of dental care
Other outcomes:
Locations:
city: Aulnay-sous-Bois
country: France
facility: Centre Hopitalier Intercommunal Robert Ballanger
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Le Kremlin-Bicêtre
country: France
facility: CHU Bicêtre
city: Montfermeil
country: France
facility: Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Study officials:
References: