PulpitisSMART-PULPNCT07450235
Measurement of Pro-resolving Inflammation Biomarkers in Saliva, Gingival Fluid, and Dental Pulp in Patients With Symptomatic Pulpitis and Healthy Controls
An observational study of Pulpitis and Healthy, run by Université de Nantes at 1 site in France.
Trial summary
This observational study aims to better understand inflammation inside the dental pulp (the inner tissue of the tooth) in patients with symptomatic pulpitis compared with healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients consulting at the dental clinic of Nantes University Hospital.
Who may be able to join
- Age ≥ 18 years, male or female.
- Patient consulting for symptomatic pulpitis (confirmed clinical and radiographic diagnosis) or for wisdom tooth extraction (healthy subject).
- Patient able to understand the research and having signed a written consent form.
- Permanent teeth only.
Who cannot join
- Refusal to participate.
- Pregnancy or breastfeeding.
- Antibiotic or anti-inflammatory treatment in the week prior to sampling.
- Clinically diagnosed inflammatory gingival or periodontal disease (gingivitis or periodontitis)
- Chronic systemic inflammatory disease (e.g., uncontrolled diabetes, autoimmune diseases).
- Patients under guardianship, conservatorship, or legal protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Nantes University Hospital Dental Clinic
Nantes, Loire-Atlantique, 44 000
Juliette Mme Jamoneau, PhD Student, 0240412982, juliette.jamoneau@etu.univ-nantes.fr
About this study
Official title: Strategic Inflammation Modulation and Advanced Regenerative Therapy of Dental PULP
This observational study aims to better understand inflammation inside the dental pulp (the inner tissue of the tooth) in patients with symptomatic pulpitis compared with healthy individuals.
Researchers will measure inflammation-related biomarkers in saliva, gingival fluid, and dental pulp samples to determine whether these substances reflect the level of inflammation.
The study also evaluates whether saliva and oral fluids could be used as simple, non-invasive tools to detect and monitor pulp inflammation.
We hypothesize that patients with pulpitis will show different biomarker levels compared with healthy controls.
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Healthy group (healthy patients undergoing wisdom tooth extraction for orthodontic or prophylactic reasons) | |
| Patients with pulpitis | Sick group (patients with symptomatic pulpitis requiring endodontic treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement Compare LXA4 and RvE1 levels in saliva, gingival crevicular fluid, and dental pulp in patients with dental pulpitis and healthy subjects.
Average concentration of LXA4 and RvE1 (expressed in pg/mL or ng/mL) measured by mass spectrometry in each type of biological sample, compared between the pulpitis group and the healthy group.
Measured: Day 0 (initial visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PulpitisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Université de Nantes
- Sponsor type
- University, hospital or other
- Collaborators
- Nantes University Hospital
- Responsible party
- Principal investigator, Alexis Gaudin, Université de Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450235
- Sponsor's protocol ID
- GNEDS-AVIS-25-116-12-030
- Acronym
- SMART-PULP
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized participant data (including age, gender, clinical dental characteristics, LXA4 and RvE1 concentrations in saliva/crevicular fluid/pulp, mass spectrometry results), collected during the initial visit to the dental clinic at Nantes University Hospital.
Publications
Khoshbin E, Salehi R, Behroozi R, Sadr S, Zamani A, Farhadian M, Karkehabadi H. The effect of low-dose aspirin on aspirin triggered lipoxin, interleukin 1 beta, and prostaglandin E2 levels in periapical fluid: a double-blind randomized clinical trial. BMC Oral Health. 2023 Jul 31;23(1):530. doi: 10.1186/s12903-023-03243-0.
PubMed 37525211
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategic Inflammation Modulation and Advanced Regenerative Therapy of Dental PULP
- ClinicalTrials.gov ID
- NCT07450235
- Acronym / sponsor ID
- SMART-PULP / GNEDS-AVIS-25-116-12-030
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Université de NantesUniversity, hospital or other
- Collaborators
- Nantes University Hospital
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Mar 2026 (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.
This observational study aims to better understand inflammation inside the dental pulp (the inner tissue of the tooth) in patients with symptomatic pulpitis compared with healthy individuals.
Researchers will measure inflammation-related biomarkers in saliva, gingival fluid, and dental pulp samples to determine whether these substances reflect the level of inflammation.
The study also evaluates whether saliva and oral fluids could be used as simple, non-invasive tools to detect and monitor pulp inflammation.
We hypothesize that patients with pulpitis will show different biomarker levels compared with healthy controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy patients | – | –Healthy group (healthy patients undergoing wisdom tooth extraction for orthodontic or prophylactic reasons) |
| Patients with pulpitis | – | –Sick group (patients with symptomatic pulpitis requiring endodontic treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients consulting at the dental clinic of Nantes University Hospital.
Key inclusion criteria (4 listed)
- Age ≥ 18 years, male or female.
- Patient consulting for symptomatic pulpitis (confirmed clinical and radiographic diagnosis) or for wisdom tooth extraction (healthy subject).
- Patient able to understand the research and having signed a written consent form.
- Permanent teeth only.
Key exclusion criteria (6 listed)
- Refusal to participate.
- Pregnancy or breastfeeding.
- Antibiotic or anti-inflammatory treatment in the week prior to sampling.
- Clinically diagnosed inflammatory gingival or periodontal disease (gingivitis or periodontitis)
- Chronic systemic inflammatory disease (e.g., uncontrolled diabetes, autoimmune diseases).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement Compare LXA4 and RvE1 levels in saliva, gingival crevicular fluid, and dental pulp in patients with dental pulpitis and healthy subjects.
Time frame: Day 0 (initial visit)
Average concentration of LXA4 and RvE1 (expressed in pg/mL or ng/mL) measured by mass spectrometry in each type of biological sample, compared between the pulpitis group and the healthy group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 37525211Khoshbin E, Salehi R, Behroozi R, Sadr S, Zamani A, Farhadian M, Karkehabadi H. The effect of low-dose aspirin on aspirin triggered lipoxin, interleukin 1 beta, and prostaglandin E2 levels in periapical fluid: a double-blind randomized clinical trial. BMC Oral Health. 2023 Jul 31;23(1):530. doi: 10.1186/s12903-023-03243-0.
- Individual participant dataSharing planned: Yes. Pseudonymized participant data (including age, gender, clinical dental characteristics, LXA4 and RvE1 concentrations in saliva/crevicular fluid/pulp, mass spectrometry results), collected during the initial visit to the dental clinic at Nantes University Hospital.
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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.
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 Pulpitis and Healthy, run by Université de Nantes 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 4 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis Mr Gaudin, Professor (+33240412913, Alexis.Gaudin@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement Compare LXA4 and RvE1 levels in saliva, gingival crevicular fluid, and dental pulp in patients with dental pulpitis and healthy subjects. (time frame: Day 0 (initial visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07450235, which also lists 1 linked publication.
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 4 Mar 2026.