Diagnostic Markers of Neuropathic Odontalgia (DIAMOND-1)

Diagnostic Markers of Neuropathic Odontalgia : Proof of Concept Study

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).

Study Overview

• Status: Unknown
• Conditions: Oral Mucosa
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Nathan MOREAU, DDS, PhD; Phone Number: +33 (0)1 53 11 14 18; Email: nathan.moreau@aphp.fr

Study Locations

• France
  • Paris, France, 75018
    • Bretonneau Hospital
    • Contact: Nathan MOREAU, DDS, PhD; Phone Number: +33 (0)1 53 11 14 18; Email: nathan.moreau@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: neuropathic pain; painful post-traumatic trigeminal neuropathy; neuropathic odontalgia; gingival biopsy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache
• Other Study ID Numbers: AP-HP190545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No