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

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ClinicalTrials.gov Identifier: NCT04085536
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Chronic Maxillary Sinusitis Procedure: Dental and medical treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Prospective Longitudinal Study on the Efficacy of Exclusive Odontological and Medical Treatment in the Management of Chronic Dental Maxillary Sinusitis
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : October 15, 2021
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Chronic maxillary sinusitis(for more than 12 weeks)
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
If the dental cause of sinusitis is objective, if necessary, dental treatment combined with medical treatment will be carried out.




Primary Outcome Measures :
  1. Number of therapeutic successes [ Time Frame: 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 :
  1. Number of dental origin [ Time Frame: 3 months after the end of dental care ]
    Patients whose dental origin has been identified

  2. Percentage of patients with preserved teeth [ Time Frame: 3 months after the end of dental care ]
    Percentage of patients who received conservative treatment of the tooth versus non-conservative dental treatment

  3. Percentage of each type of dental disease causing chronic maxillary sinusitis [ Time Frame: 3 months after the end of dental care ]
    Measure the prevalence of the different dental diseases that cause sinusitis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04085536


Contacts
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Contact: Camille JUNG, MD 01 57 02 22 68 ext +33 camille.jung@chicreteil.fr

Locations
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France
Centre Hopitalier Intercommunal Robert Ballanger Not yet recruiting
Aulnay-sous-Bois, France, 93600
Contact: ROSIKON Andrzej, MD    01 45 36 71 23    andrzej.rosikon@ch-aulnay.fr   
Centre Hospitalier Intercommunal de Créteil Recruiting
Créteil, France, 94000
Contact: Héloïse DE KERMADEC, MD    01 45 17 54 50 ext +33(1)    Eloise.DeKermadec@chicreteil.fr   
Hôpital Henri Mondor Not yet recruiting
Créteil, France, 94010
Contact: Emilie BEQUIGNON, MD    01 49 81 24 91 ext +33 (1)    emilie.bequignon@gmail.com   
CHU Bicêtre Not yet recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Jean-François PAPON, PhD    01 45 21 36 81 ext +33(1)    jean-francois.papon@aphp.fr   
Groupe Hospitalier Intercommunal Le Raincy-Montfermeil Not yet recruiting
Montfermeil, France, 93370
Contact: Antoine GARIN, MD    01 41 70 81 42 ext +33(1)    agarin@ch-montfermeil.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
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Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT04085536    
Other Study ID Numbers: DENTASINUS
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sinusitis
Maxillary Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases