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

NCT04085536 | Unknown

• 1 other identifier: DENTASINUS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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

Conditions

Chronic Maxillary Sinusitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of dental origin

  3 months after the end of dental care

• Percentage of patients with preserved teeth

  3 months after the end of dental care

• Percentage of each type of dental disease causing chronic maxillary sinusitis

  3 months after the end of dental care

Study Arms (1)

Chronic maxillary sinusitis(for more than 12 weeks)

OTHER

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.

Procedure: Dental and medical treatment

Interventions

Dental and medical treatment PROCEDURE

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

Chronic maxillary sinusitis(for more than 12 weeks)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (5)

Centre Hopitalier Intercommunal Robert Ballanger

Aulnay-sous-Bois, 93600, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Groupe Hospitalier Intercommunal Le Raincy-Montfermeil

Montfermeil, 93370, France

Location

MeSH Terms

Interventions

Dental Health Services

Intervention Hierarchy (Ancestors)

Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 11, 2019
• Study Start: October 16, 2019
• Primary Completion: July 30, 2023
• Study Completion: September 15, 2023
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)