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Not yet recruitingNCT07450235SMART-PULPUpdated Mar 4, 2026

Measurement of Pro-resolving Inflammation Biomarkers in Saliva, Gingival Fluid, and Dental Pulp in Patients With Symptomatic Pulpitis and Healthy Controls

An observational study in Pulpitis and Healthy, sponsored by Université de Nantes. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.

Sponsored by Université de Nantes · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

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.

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Conditions studied

  • Pulpitis
  • Healthy

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03

In context

Pulpitis

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

This study's planned enrollment of 50 is below the median of 75 across 23 observational studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Université de Nantes is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients consulting at the dental clinic of Nantes University Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria

  • 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, diseases).
  • Patients under guardianship, conservatorship, or legal protection
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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)

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 0 (initial visit)

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Study locations

1 site
  • Nantes University Hospital Dental Clinic
    Nantes, Loire-Atlantique 44 000, France
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References and documents

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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2026; primary completion for Jul 2028, 28 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 26, 2026
First posted
Mar 4, 2026
StartEst.
Mar 1, 2026
Primary completionEst.
Jul 2028
CompletionEst.
Dec 2028
Last update
Mar 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07450235
Lead sponsor
Université de Nantes
Responsible party
Alexis Gaudin (Professor, Université de Nantes) — Principal investigator
First posted
Mar 4, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Mar 4, 2026

Study contacts

Alexis Mr Gaudin, Professor
Contact
Alexis.Gaudin@univ-nantes.fr
+33240412913

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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