Characterization of Pulp Inflammation: an Observational Study Using Biological Samples Collected During Routine Dental Care

NCT07533396 | Not Yet Recruiting

• 1 other identifier: APHP250930
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: Vital pulp therapy (VPT) is a cornerstone of minimally invasive dentistry and aims to preserve pulp vitality whenever clinically feasible. Teeth with vital pulp show better long-term survival than endodontically treated teeth. However, the success of VPT procedures-such as indirect or direct pulp capping, partial pulpotomy, and full pulpotomy-critically depends on an accurate assessment of the extent and severity of pulpal inflammation. Current diagnostic classifications are mainly based on patient-reported symptoms and sensibility tests, which do not reliably reflect the underlying inflammatory status of the pulp tissue. This diagnostic uncertainty contributes to inappropriate treatment selection, early therapeutic failures, and wide variability in clinical practice. Rationale: Pulpal inflammation is a dynamic and spatially heterogeneous biological process that progresses from localized to diffuse tissue involvement. Clinical studies have demonstrated discrepancies between clinical diagnosis and the actual histological and molecular status of the pulp. A new diagnostic classification (Endolight) has been proposed to better guide VPT indications by distinguishing different stages of pulpal inflammation, but it has not yet been validated against in situ biological analyses of human pulp tissue. Moreover, the identification of molecular and protein biomarkers associated with inflammatory severity could support the development of more accurate diagnostic and prognostic tools for endodontic decision-making. Objectives: The primary objective of this study is to characterize the immune and inflammatory response of human dental pulp at the tissue, transcriptomic, and proteomic levels using biological samples obtained during routine dental care. Secondary objectives are to assess the concordance between clinical diagnostic categories-particularly those of the Endolight classification-and pulpal inflammatory profiles, and to explore associations between inflammatory profiles and patient-related or tooth-related factors. Methods: This is a prospective, monocentric observational study conducted at the Department of Dental Medicine of Pitié-Salpêtrière Hospital. Pulp tissue samples and whole pulp-containing teeth are collected as operative waste during routine endodontic treatments or tooth extractions. Samples are pseudonymized and processed according to the planned analyses. Transcriptomic profiling is performed using RNA sequencing, with validation by RT-qPCR, in situ hybridization and RNAscope. Protein expression and activity are assessed using proteomic approaches, ELISA assays, and immunohistochemical or immunofluorescence analyses. Clinical, demographic, and dental data are collected from medical records using a secured electronic case report form. Outcomes: Primary outcomes include the identification and characterization of inflammatory gene and protein expression profiles in human dental pulp. Secondary outcomes include the concordance between clinical diagnoses and biological inflammatory profiles, as well as the identification of molecular biomarkers potentially relevant for guiding VPT indications. Expected impact: By improving the biological characterization of pulpal inflammation and its relationship with clinical diagnosis, this study aims to support more precise, biology-driven decision-making in vital pulp therapy and the management of endodontic emergencies.

Conditions

Pulpal Inflammation

Keywords

Pulpitis; human pulp; diagnosis; vital pulp therapy

Outcome Measures

Primary Outcomes (1)

• Gene expression levels in inflamed dental pulp tissues

  Quantitative assessment of gene expression levels using RNA sequencing (normalized expression counts), comparing different clinical diagnosis of pulpitis (according to Endolight classification).

  At the time of pulp tissue collection (baseline)

Secondary Outcomes (6)

• Relative gene expression validation by RT-qPCR profile

  At the time of pulp tissue collection (baseline)

• Protein concentration levels in inflamed dental pulp tissues

  At the time of pulp tissue collection (baseline)

• Protein abundance profiles by mass spectrometry

  Assessment of protein abundance and degradation patterns using mass spectrometry-based proteomics (relative intensity or spectral counts).

• Cytokines expression in pulp tissues

  At the time of pulp tissue collection (baseline)

• Association between molecular markers and clinical parameters

  At the time of pulp tissue collection (baseline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years old) whose pulp tissue must be removed during routine dental care, either through endodontic treatment or tooth extraction for orthodontic, surgical, prosthetic, or periodontal reasons. \- Patients who have been informed about the study and have not expressed opposition to participation

You may qualify if:

• \- Adult patients (≥18 years old) whose pulp tissue must be removed during routine dental care, either through endodontic treatment or tooth extraction for orthodontic, surgical, prosthetic, or periodontal reasons.
• Patients who have been informed about the study and have not expressed opposition to participation

You may not qualify if:

• \- Patients who have taken anti-inflammatory medication within 12 hours prior to the dental procedure.
• Patients under legal protection measures (e.g., guardianship or curatorship).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Pulpitis; Disease

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marjorie ZANINI, Dental surgeon, Associate Prof

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marjolaine GOSSET, Dental surgeon, Professor

CONTACT

33682776276; marjolaine.gosseti@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: April 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.