DIAMOND-1: Diagnostic Markers of Neuropathic Odontalgia

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04142918
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 5

Study Details

Study Description

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	Phase
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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 45 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Diagnostic Markers of Neuropathic Odontalgia : Proof of Concept Study
• Anticipated Study Start Date: Jun 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Mar 1, 2021

Outcome Measures

Primary Outcome Measures

1. Patched-1 Western Blot concentration [Baseline]

   Patched-1 will be measured in oral mucosa/gingiva samples using Western Blot

2. Patched-1 immunohistochemistry concentration [Baseline]

   Patched-1 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)

3. Patched-1 ELISA concentration [Baseline]

   Patched-1 will be measured in oral mucosa/gingiva samples using ELISA

4. Frizzled-7 Western Blot concentration [Baseline]

   Frizzled-7 will be measured in oral mucosa/gingiva samples using Western Blot

5. Frizzled-7 immunohistochemistry concentration [Baseline]

   Frizzled-7 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)

6. Frizzled-7 ELISA concentration [Baseline]

   Frizzled-7 will be measured in oral mucosa/gingiva samples using ELISA

7. Claudin-5 Western Blot concentration [Baseline]

   Claudin-5 will be measured in oral mucosa/gingiva samples using Western Blot

8. Claudin-5 immunohistochemistry concentration [Baseline]

   Claudin-5 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)

9. Claudin-5 ELISA concentration [Baseline]

   Claudin-5 will be measured in oral mucosa/gingiva samples using ELISA

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bretonneau Hospital	Paris		France	75018

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

• Principal Investigator: Nathan MOREAU, DDS, PhD, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04142918
• Other Study ID Numbers: AP-HP190545
• First Posted: Oct 29, 2019
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Toothache

Study Results

No Results Posted as of Mar 25, 2020