Oral MucosaDIAMOND-1NCT04142918
Diagnostic Markers of Neuropathic Odontalgia
An observational study of Oral Mucosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucosa
- What is being tested?
- Immunostaining
- Type of treatment
- Pill or oral medicine
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 1 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients requiring an oral/dental surgical intervention that will generate gingival/mucosal tissue elimination (as part of the normal surgical procedure)
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Bretonneau Hospital
Paris, 75018
Nathan MOREAU, DDS, PhD, (0)1 53 11 14 18 ext. +33, nathan.moreau@aphp.fr
About this study
Official title: 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).
Read the 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.
- Conditions
- Oral Mucosa
- Being tested
- Immunostaining
- Keywords
- painful post-traumatic trigeminal neuropathy, neuropathic pain, neuropathic odontalgia, gingival biopsy
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunostainingOther
Immunostaining of oral mucosa/gingiva samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Patched-1 Western Blot concentration
Patched-1 will be measured in oral mucosa/gingiva samples using Western Blot
Measured: Baseline
Patched-1 immunohistochemistry concentration
Patched-1 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Measured: Baseline
Patched-1 ELISA concentration
Patched-1 will be measured in oral mucosa/gingiva samples using ELISA
Measured: Baseline
Frizzled-7 Western Blot concentration
Frizzled-7 will be measured in oral mucosa/gingiva samples using Western Blot
Measured: Baseline
Frizzled-7 immunohistochemistry concentration
Frizzled-7 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Measured: Baseline
Frizzled-7 ELISA concentration
Frizzled-7 will be measured in oral mucosa/gingiva samples using ELISA
Measured: Baseline
Claudin-5 Western Blot concentration
Claudin-5 will be measured in oral mucosa/gingiva samples using Western Blot
Measured: Baseline
Claudin-5 immunohistochemistry concentration
Claudin-5 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Measured: Baseline
Claudin-5 ELISA concentration
Claudin-5 will be measured in oral mucosa/gingiva samples using ELISA
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Jun 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan MOREAU, DDS, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142918
- Sponsor's protocol ID
- AP-HP190545
- Acronym
- DIAMOND-1
- Status last verified
- Mar 2020
- First submitted
- 25 Oct 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Markers of Neuropathic Odontalgia : Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04142918
- Acronym / sponsor ID
- DIAMOND-1 / AP-HP190545
- Conditions
- Oral Mucosa
- Keywords
- painful post-traumatic trigeminal neuropathy, neuropathic pain, neuropathic odontalgia, gingival biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients requiring an oral/dental surgical intervention that will generate gingival/mucosal tissue elimination (as part of the normal surgical procedure)
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunostainingImmunostaining of oral mucosa/gingiva samples | Other | – |
Primary outcome
Patched-1 Western Blot concentration
Time frame: Baseline
Patched-1 will be measured in oral mucosa/gingiva samples using Western Blot
Patched-1 immunohistochemistry concentration
Time frame: Baseline
Patched-1 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Patched-1 ELISA concentration
Time frame: Baseline
Patched-1 will be measured in oral mucosa/gingiva samples using ELISA
Frizzled-7 Western Blot concentration
Time frame: Baseline
Frizzled-7 will be measured in oral mucosa/gingiva samples using Western Blot
Frizzled-7 immunohistochemistry concentration
Time frame: Baseline
Frizzled-7 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Frizzled-7 ELISA concentration
Time frame: Baseline
Frizzled-7 will be measured in oral mucosa/gingiva samples using ELISA
Claudin-5 Western Blot concentration
Time frame: Baseline
Claudin-5 will be measured in oral mucosa/gingiva samples using Western Blot
Claudin-5 immunohistochemistry concentration
Time frame: Baseline
Claudin-5 will be measured in oral mucosa/gingiva samples using immunohistochemistry (IHC)
Claudin-5 ELISA concentration
Time frame: Baseline
Claudin-5 will be measured in oral mucosa/gingiva samples using ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan MOREAU, DDS, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Mucosa, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathan MOREAU, DDS, PhD ((0)1 53 11 14 18 ext. +33, nathan.moreau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patched-1 Western Blot concentration (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.