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

NCT07450235 | Not Yet Recruiting DMC

• 1 other identifier: GNEDS-AVIS-25-116-12-030
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulpitis; Healthy

Outcome Measures

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.

  Day 0 (initial visit)

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients consulting at the dental clinic of Nantes University Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Nantes: lead
• Nantes University Hospital: collaborator

Study Sites (1)

Nantes University Hospital Dental Clinic

Nantes, Loire-Atlantique, 44 000, France

Location

Related Publications (1)

• 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.

  PMID: 37525211 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dental pulp, Saliva, gingival crevicular fluid

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Alexis Mr Gaudin, Professor

CONTACT

+33240412913; Alexis.Gaudin@univ-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

FR (1)