Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 1:19 AM
Study NCT ID:
NCT07443605
Status:
COMPLETED
Last Update Posted:
2026-03-04
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cortisol and dehydroepiandrosterone sulfate', 'timeFrame': '3 months', 'description': 'cortisol (pg/mg) and dehydroepiandrosterone Sulfate (pg/mg) present in the hair of periodontal patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CORTISOL', 'HAIR', 'STRESS', 'PERIODONTITIS', 'DEHYDROEPIANDROSTERONE SULFATE'], 'conditions': ['Stress Disorders']}, 'descriptionModule': {'briefSummary': 'This study was designed with a double-blind observation design on a population of patients with different periodontal conditions.\n\nThe aim is to assess the influence of allostatic loading through the dosage of cortisol, DHEA, DHEAS in both periodontitis pathogenesis and non-surgical periodontal treatment.\n\nThe NNT will be built on the biases related to the pathologies in existence. The indicative number of patients is around 100 units and samples will be taken at t0 (baseline, dental visit with periodontal evaluation) and t60 (60 days after non-surgical periodontal treatment). For this study there is no randomization of groups, the dental treatments that will be performed will be in the usual clinical practice and will not be in any way influenced by the objectives of the study.\n\nMATERIALS AND METHODS:\n\nAt baseline, the periodontal chart will be performed, a SVS (Stress-Related Vulnerability Scale) test questionnaire will be taken and biological markers will be evaluated by taking a small strand of hair. The same revaluations will also be carried out at 60 days.\n\nPatients will also be recruited according to an information system, training and will be given a paper informed consent in accordance with the current legislation which is attached.\n\nThe sample once taken will be kept at the health facility until the analysis of the sample and the results will then be communicated to the patient within 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPeriodontitis stages III or IV\n\nExclusion Criteria:\n\n\\< 18 years or \\> 70 years pregnant or lactating females Periodontal treatment in the previous 6 months'}, 'identificationModule': {'nctId': 'NCT07443605', 'briefTitle': 'Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Trieste'}, 'officialTitle': 'Allostatic Load Assessment Using Hair Cortisol and Dehydroepiandrosterone Sulfate Concentration in Patients Affected by Periodontal Disease.', 'orgStudyIdInfo': {'id': 'BLorenzo1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Hair markers levels in stressed periodontal patients', 'interventionNames': ['Diagnostic Test: stressed periodontal patients']}], 'interventions': [{'name': 'stressed periodontal patients', 'type': 'DIAGNOSTIC_TEST', 'description': 'A hair strand of about 3 mm in diameter was collected from all the patients, cut at the scalp in the position of the posterior vertex and the nuchal area of the patient enrolled so as not to change or alter the aesthetic appearance a significant levy. The proximal hair segment of 1 cm was used for analysis. The average hair growth rate of 1 cm/month represents the catabolism of cortisol and dehydroepiandrosterone sulfate (DHEAS) in the hair, in the month preceding the periodontal evaluation.', 'armGroupLabels': ['Hair markers levels in stressed periodontal patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34125', 'city': 'Trieste', 'state': 'TS', 'country': 'Italy', 'facility': 'University of Trieste', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Trieste', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, Msc Clinical Department of Medical Sciences, Surgery and Healt, University of Trieste, Trieste, Italy', 'investigatorFullName': 'Bevilacqua Lorenzo', 'investigatorAffiliation': 'University of Trieste'}}}}