Prospective Study on the Efficacy of Exclusive Odontological and Medical Treatment in Chronic Dental Maxillary Sinusitis (DENTASINUS)
Primary Purpose
Chronic Maxillary Sinusitis
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dental and medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Maxillary Sinusitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Centre Hopitalier Intercommunal Robert Ballanger
- Centre Hospitalier Intercommunal de Créteil
- Hôpital Henri Mondor
- CHU Bicêtre
- Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Chronic maxillary sinusitis(for more than 12 weeks)
Arm 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.
Outcomes
Primary Outcome Measures
Number of therapeutic successes
Disappearance of symptoms and absence of pus from the meatus observed at the 2nd consultation visit ENT control
Secondary Outcome Measures
Number of dental origin
Patients whose dental origin has been identified
Percentage of patients with preserved teeth
Percentage of patients who received conservative treatment of the tooth versus non-conservative dental treatment
Percentage of each type of dental disease causing chronic maxillary sinusitis
Measure the prevalence of the different dental diseases that cause sinusitis
Full Information
NCT ID
NCT04085536
First Posted
September 9, 2019
Last Updated
June 6, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
1. Study Identification
Unique Protocol Identification Number
NCT04085536
Brief Title
Prospective Study on the Efficacy of Exclusive Odontological and Medical Treatment in Chronic Dental Maxillary Sinusitis
Acronym
DENTASINUS
Official Title
Multicenter Prospective Longitudinal Study on the Efficacy of Exclusive Odontological and Medical Treatment in the Management of Chronic Dental Maxillary Sinusitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Maxillary Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chronic maxillary sinusitis(for more than 12 weeks)
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Dental and medical treatment
Intervention Description
If the dental cause of sinusitis is objective, if necessary, dental treatment combined with medical treatment will be carried out.
Primary Outcome Measure Information:
Title
Number of therapeutic successes
Description
Disappearance of symptoms and absence of pus from the meatus observed at the 2nd consultation visit ENT control
Time Frame
3 months after the end of dental care
Secondary Outcome Measure Information:
Title
Number of dental origin
Description
Patients whose dental origin has been identified
Time Frame
3 months after the end of dental care
Title
Percentage of patients with preserved teeth
Description
Percentage of patients who received conservative treatment of the tooth versus non-conservative dental treatment
Time Frame
3 months after the end of dental care
Title
Percentage of each type of dental disease causing chronic maxillary sinusitis
Description
Measure the prevalence of the different dental diseases that cause sinusitis
Time Frame
3 months after the end of dental care
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Centre Hopitalier Intercommunal Robert Ballanger
City
Aulnay-sous-Bois
ZIP/Postal Code
93600
Country
France
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Facility Name
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
City
Montfermeil
ZIP/Postal Code
93370
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Study on the Efficacy of Exclusive Odontological and Medical Treatment in Chronic Dental Maxillary Sinusitis
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