Diagnostic Markers of Neuropathic Odontalgia

Oral Mucosa Clinical Trial

— DIAMOND-1  

Official title:

Diagnostic Markers of Neuropathic Odontalgia : Proof of Concept Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04142918
• Other study ID #: AP-HP190545
• Status: Not yet recruiting
• Start date: June 1, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nathan MOREAU, DDS, PhD
• Phone: (0)1 53 11 14 18
• Email: nathan.moreau[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: March 1, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oral Mucosa
• Toothache

Intervention

Other:
• Immunostaining
Immunostaining of oral mucosa/gingiva samples

Locations

Country	Name	City	State
France	Bretonneau Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patched-1 Western Blot concentration	Patched-1 will be measured in oral mucosa/gingiva samples using Western Blot	Baseline
Primary	Patched-1 immunohistochemistry concentration	Patched-1 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)	Baseline
Primary	Patched-1 ELISA concentration	Patched-1 will be measured in oral mucosa/gingiva samples using ELISA	Baseline
Primary	Frizzled-7 Western Blot concentration	Frizzled-7 will be measured in oral mucosa/gingiva samples using Western Blot	Baseline
Primary	Frizzled-7 immunohistochemistry concentration	Frizzled-7 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)	Baseline
Primary	Frizzled-7 ELISA concentration	Frizzled-7 will be measured in oral mucosa/gingiva samples using ELISA	Baseline
Primary	Claudin-5 Western Blot concentration	Claudin-5 will be measured in oral mucosa/gingiva samples using Western Blot	Baseline
Primary	Claudin-5 immunohistochemistry concentration	Claudin-5 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)	Baseline
Primary	Claudin-5 ELISA concentration	Claudin-5 will be measured in oral mucosa/gingiva samples using ELISA	Baseline