Prospective Study on the Efficacy of Exclusive Odontological and Medical Treatment in Chronic Dental Maxillary Sinusitis (DENTASINUS)

Centre Hospitalier Intercommunal Creteil

Status: Active, not recruiting

Conditions: Chronic Maxillary Sinusitis

Treatments: Procedure: Dental and medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04085536

DENTASINUS

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Chronic maxillary sinusitis(for more than 12 weeks)

Other group

Description:

Patients for whom chronic maxillary sinusitis will be diagnosed in the first ENT consultation, will then be seen in a stomatology consultation to determine whether or not a dental cause is objective.

Treatment:

Procedure: Dental and medical treatment