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

February 26, 2026 updated by: Alexis Gaudin, Université de Nantes

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44 000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients consulting at the dental clinic of Nantes University Hospital.

Description

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

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 (initial visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Nantes

Collaborators

Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GNEDS-AVIS-25-116-12-030

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe