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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

Tracking Information
First Submitted Date  ICMJE September 9, 2019
First Posted Date  ICMJE September 11, 2019
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE October 16, 2019
Estimated Primary Completion Date October 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2019)
  • Number of dental origin [ Time Frame: 3 months after the end of dental care ]
    Patients whose dental origin has been identified
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study on the Efficacy of Exclusive Odontological and Medical Treatment in Chronic Dental Maxillary Sinusitis
Official Title  ICMJE Multicenter Prospective Longitudinal Study on the Efficacy of Exclusive Odontological and Medical Treatment in the Management of Chronic Dental Maxillary Sinusitis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Maxillary Sinusitis
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Procedure: Dental and medical treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2022
Estimated Primary Completion Date October 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Camille JUNG, MD 01 57 02 22 68 ext +33 camille.jung@chicreteil.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04085536
Other Study ID Numbers  ICMJE DENTASINUS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Intercommunal Creteil
Study Sponsor  ICMJE Centre Hospitalier Intercommunal Creteil
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Intercommunal Creteil
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP