Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:27 AM
Study NCT ID:
NCT07450235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Pro-resolving Inflammation Biomarkers in Saliva, Gingival Fluid, and Dental Pulp in Patients With Symptomatic Pulpitis and Healthy Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011671', 'term': 'Pulpitis'}], 'ancestors': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Dental pulp, Saliva, gingival crevicular fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2026-02-26', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement Compare LXA4 and RvE1 levels in saliva, gingival crevicular fluid, and dental pulp in patients with dental pulpitis and healthy subjects.', 'timeFrame': 'Day 0 (initial visit)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulpitis', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '37525211', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nResearchers will measure inflammation-related biomarkers in saliva, gingival fluid, and dental pulp samples to determine whether these substances reflect the level of inflammation.\n\nThe study also evaluates whether saliva and oral fluids could be used as simple, non-invasive tools to detect and monitor pulp inflammation.\n\nWe hypothesize that patients with pulpitis will show different biomarker levels compared with healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients consulting at the dental clinic of Nantes University Hospital.', 'eligibilityCriteria': 'Inclusion criteria\n\n* Age ≥ 18 years, male or female.\n* Patient consulting for symptomatic pulpitis (confirmed clinical and radiographic diagnosis) or for wisdom tooth extraction (healthy subject).\n* Patient able to understand the research and having signed a written consent form.\n* Permanent teeth only.\n\nExclusion criteria\n\n* Refusal to participate.\n* Pregnancy or breastfeeding.\n* Antibiotic or anti-inflammatory treatment in the week prior to sampling.\n* Clinically diagnosed inflammatory gingival or periodontal disease (gingivitis or periodontitis)\n* Chronic systemic inflammatory disease (e.g., uncontrolled diabetes, autoimmune diseases).\n* Patients under guardianship, conservatorship, or legal protection'}, 'identificationModule': {'nctId': 'NCT07450235', 'acronym': 'SMART-PULP', 'briefTitle': 'Measurement of Pro-resolving Inflammation Biomarkers in Saliva, Gingival Fluid, and Dental Pulp in Patients With Symptomatic Pulpitis and Healthy Controls', 'organization': {'class': 'OTHER', 'fullName': 'Université de Nantes'}, 'officialTitle': 'Strategic Inflammation Modulation and Advanced Regenerative Therapy of Dental PULP', 'orgStudyIdInfo': {'id': 'GNEDS-AVIS-25-116-12-030'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy patients', 'description': 'Healthy group (healthy patients undergoing wisdom tooth extraction for orthodontic or prophylactic reasons)'}, {'label': 'Patients with pulpitis', 'description': 'Sick group (patients with symptomatic pulpitis requiring endodontic treatment)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44 000', 'city': 'Nantes', 'state': 'Loire-Atlantique', 'country': 'France', 'contacts': [{'name': 'Juliette Mme Jamoneau, PhD Student', 'role': 'CONTACT', 'email': 'juliette.jamoneau@etu.univ-nantes.fr', 'phone': '0240412982'}], 'facility': 'Nantes University Hospital Dental Clinic', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Alexis Mr Gaudin, Professor', 'role': 'CONTACT', 'email': 'Alexis.Gaudin@univ-nantes.fr', 'phone': '+33240412913'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Nantes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nantes University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Alexis Gaudin', 'investigatorAffiliation': 'Université de Nantes'}}}}