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Diagnostic Markers of Neuropathic Odontalgia (DIAMOND-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04142918
Recruitment Status : Not yet recruiting
First Posted : October 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The DIAMOND study aims to investigate the presence and diagnostic relevance of potential biomarkers of the blood-nerve barrier disruption as surrogate markers of painful post-traumatic trigeminal neuropathic pain in patients presenting with neuropathic odontalgia. The first part of the study explores the proof-of-concept and technical feasibility of intra-epithelial nerve fiber immunostaining in gingival/oral mucosa biopsies and the potential presence of these biomarkers in healthy patients (baseline condition).

Condition or disease Intervention/treatment
Oral Mucosa Other: Immunostaining

Detailed Description:

Painful Post-Traumatic Trigeminal Neuropathy (PPTTN) defines a neuropathic painful condition affecting the orofacial region, following local nerve trauma, usually secondary to dental treatments (tooth avulsion, root canal treatments….). It often presents as odontalgia of atypical presentation, unresponsive to conventional treatments. The diagnostic is often complex (and often is a diagnosis of elimination), leading to unnecessary iatrogenic dental treatments and insufficient pain relief.

This study aims to explore potential new markers of PPTTN, based on a translational approach following previous preclinical work that showed the importance of the disruption of the blood-nerve barrier in generating post-traumatic neuropathic pain. Several markers of such disruption have been highlighted (such as Claudin-5, Patched-1 and Frizzled-7) that could be specifically downregulated in neuropathic pain conditions (as compared to inflammatory neuritis conditions). As such, these markers could be interesting biomarkers of neuropathic pain. This study aims to explore the presence (and absence) of such markers in healthy vs neuropathic patients respectively.

The first part of the study investigates the technical feasibility of intra-epithelial nerve fiber staining in oral mucosa/gingiva specimens collected in healthy patients (undergoing routine oral surgery procedures) and the immunoreactivity/presence of such biomarkers in those specimens.

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Diagnostic Markers of Neuropathic Odontalgia : Proof of Concept Study
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Other: Immunostaining
    Immunostaining of oral mucosa/gingiva samples


Primary Outcome Measures :
  1. Patched-1 Western Blot concentration [ Time Frame: Baseline ]
    Patched-1 will be measured in oral mucosa/gingiva samples using Western Blot

  2. Patched-1 immunohistochemistry concentration [ Time Frame: Baseline ]
    Patched-1 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)

  3. Patched-1 ELISA concentration [ Time Frame: Baseline ]
    Patched-1 will be measured in oral mucosa/gingiva samples using ELISA

  4. Frizzled-7 Western Blot concentration [ Time Frame: Baseline ]
    Frizzled-7 will be measured in oral mucosa/gingiva samples using Western Blot

  5. Frizzled-7 immunohistochemistry concentration [ Time Frame: Baseline ]
    Frizzled-7 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)

  6. Frizzled-7 ELISA concentration [ Time Frame: Baseline ]
    Frizzled-7 will be measured in oral mucosa/gingiva samples using ELISA

  7. Claudin-5 Western Blot concentration [ Time Frame: Baseline ]
    Claudin-5 will be measured in oral mucosa/gingiva samples using Western Blot

  8. Claudin-5 immunohistochemistry concentration [ Time Frame: Baseline ]
    Claudin-5 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)

  9. Claudin-5 ELISA concentration [ Time Frame: Baseline ]
    Claudin-5 will be measured in oral mucosa/gingiva samples using ELISA


Biospecimen Retention:   Samples Without DNA
Oral mucosa biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients requiring an oral/dental surgical intervention that will generate gingival/mucosal tissue elimination (as part of the normal surgical procedure)
Criteria

Inclusion Criteria:

Adult patients (over 18 years old) requiring an oral/dental surgical intervention that will generate gingival/mucosal tissue elimination (as part of the normal surgical procedure)

Exclusion Criteria:

  • Patient with a diagnosed odontalgia
  • Patient with Painful Post-Traumatic Trigeminal Neuropathy (PPTTN)
  • Patient with unexplained pains or a neuropathic pain regardless of its location
  • Patient under guardianship or trusteeship
  • Patient who refuses to give his/her non-opposition to participate to the study

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): NCT04142918


Contacts
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Contact: Nathan MOREAU, MD, PhD (0)1 53 11 14 18 ext +33 nathan.moreau@aphp.fr

Locations
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France
Bretonneau Hospital
Paris, France, 75018
Contact: Nathan MOREAU, MD, PhD    (0)1 53 11 14 18 ext +33    nathan.moreau@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Nathan MOREAU, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04142918    
Other Study ID Numbers: AP-HP190545
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
painful post-traumatic trigeminal neuropathy
neuropathic pain
neuropathic odontalgia
gingival biopsy
Additional relevant MeSH terms:
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Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms