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

Chronic Maxillary Sinusitis Clinical Trial

— DENTASINUS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04085536
• Other study ID #: DENTASINUS
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: September 15, 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: September 15, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Maxillary Sinusitis
• Maxillary Sinusitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of therapeutic successes	Disappearance of symptoms and absence of pus from the meatus observed at the 2nd consultation visit ENT control	3 months after the end of dental care
Secondary	Number of dental origin	Patients whose dental origin has been identified	3 months after the end of dental care
Secondary	Percentage of patients with preserved teeth	Percentage of patients who received conservative treatment of the tooth versus non-conservative dental treatment	3 months after the end of dental care
Secondary	Percentage of each type of dental disease causing chronic maxillary sinusitis	Measure the prevalence of the different dental diseases that cause sinusitis	3 months after the end of dental care