NCT04142918

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

October 25, 2019

Last Update Submit

March 24, 2020

Conditions

Oral Mucosa

Keywords

painful post-traumatic trigeminal neuropathyneuropathic painneuropathic odontalgiagingival biopsy

Outcome Measures

Primary Outcomes (9)

  • 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

Interventions

ImmunostainingOTHER

Immunostaining of oral mucosa/gingiva samples

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bretonneau Hospital

Paris, 75018, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Oral mucosa biopsy

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nathan MOREAU, DDS, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan MOREAU, DDS, PhD

CONTACT

(0)1 53 11 14 18nathan.moreau@aphp.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 29, 2019

Study Start

June 1, 2020

Primary Completion

December 1, 2020

Study Completion

March 1, 2021

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

FR(1)