Chronic Maxillary SinusitisDENTASINUSNCT04085536
Prospective Study on the Efficacy of Exclusive Odontological and Medical Treatment in Chronic Dental Maxillary Sinusitis
A study testing Dental and medical treatment in people with Chronic Maxillary Sinusitis, run by Centre Hospitalier Intercommunal Creteil at 5 sites in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Maxillary Sinusitis
- What is being tested?
- Dental and medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesFrance
- Study dates
- 16 Oct 2019to 15 Feb 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hopitalier Intercommunal Robert Ballanger
Aulnay-sous-Bois, 93600
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Hôpital Henri Mondor
Créteil, 94010
CHU Bicêtre
Le Kremlin-Bicêtre, 94270
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil
Montfermeil, 93370
About this study
Official title: Multicenter Prospective Longitudinal Study on the Efficacy of Exclusive Odontological and Medical Treatment in the Management of Chronic Dental Maxillary Sinusitis
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
Read the 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
- Being tested
- Dental and medical treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental and medical treatmentProcedure or surgery
If the dental cause of sinusitis is objective, if necessary, dental treatment combined with medical treatment will be carried out.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Dental and medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of therapeutic successes
Disappearance of symptoms and absence of pus from the meatus observed at the 2nd consultation visit ENT control
Measured: 3 months after the end of dental care
Secondary outcomes (3)
Number of dental origin
Patients whose dental origin has been identified
Measured: 3 months after the end of dental care
Percentage of patients with preserved teeth
Percentage of patients who received conservative treatment of the tooth versus non-conservative dental treatment
Measured: 3 months after the end of dental care
Percentage of each type of dental disease causing chronic maxillary sinusitis
Measure the prevalence of the different dental diseases that cause sinusitis
Measured: 3 months after the end of dental care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start16 Oct 2019
- Primary completion30 Dec 2023
- Study completion15 Feb 2024
Why it stopped: COVID crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Maxillary SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04085536
- Sponsor's protocol ID
- DENTASINUS
- Acronym
- DENTASINUS
- Status last verified
- Aug 2025
- First submitted
- 9 Sep 2019
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No