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

NCT ID: NCT04085536

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2023-09-15

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.

Conditions

Chronic Maxillary Sinusitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chronic maxillary sinusitis(for more than 12 weeks)

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.

Group Type: OTHER

Dental and medical treatment

Intervention Type: PROCEDURE

If the dental cause of sinusitis is objective, if necessary, dental treatment combined with medical treatment will be carried out.

Interventions

Dental and medical treatment

If the dental cause of sinusitis is objective, if necessary, dental treatment combined with medical treatment will be carried out.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hopitalier Intercommunal Robert Ballanger

Aulnay-sous-Bois, , France

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Hôpital Henri Mondor

Créteil, , France

CHU Bicêtre

Le Kremlin-Bicêtre, , France

Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

Montfermeil, , France

Countries

France

Other Identifiers

DENTASINUS

Identifier Type: -

Identifier Source: org_study_id