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

Not Applicable

Active, not recruiting

• Conditions: Chronic Maxillary Sinusitis
• Interventions: Procedure: Dental and medical treatment

• Registration Number: NCT04085536
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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.

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-11
• Study Start: 2019-10-16
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07
• Primary Completion: 2023-07-30
• Study Completion: 2023-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chronic maxillary sinusitis(for more than 12 weeks)	Dental and medical treatment	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.

Primary Outcome Measures

Name	Time	Method
Number of therapeutic successes	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

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with preserved teeth	3 months after the end of dental care	Percentage of patients who received conservative treatment of the tooth versus non-conservative dental treatment
Number of dental origin	3 months after the end of dental care	Patients whose dental origin has been identified
Percentage of each type of dental disease causing chronic maxillary sinusitis	3 months after the end of dental care	Measure the prevalence of the different dental diseases that cause sinusitis

Trial Locations

Locations (5)

Hôpital Henri Mondor; 🇫🇷 Créteil, France

CHU Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

Centre Hopitalier Intercommunal Robert Ballanger; 🇫🇷 Aulnay-sous-Bois, France

Groupe Hospitalier Intercommunal Le Raincy-Montfermeil; 🇫🇷 Montfermeil, France

Centre Hospitalier Intercommunal de Créteil; 🇫🇷 Créteil, France