Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-31 @ 6:02 PM
Study NCT ID:
NCT06764758
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anxiety Levels of Patients Subjected to Endodontic and Restorative Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004708', 'term': 'Endodontics'}, {'id': 'D057087', 'term': 'Dental Atraumatic Restorative Treatment'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Corah's Dental Anxiety Scale", 'timeFrame': 'Day 1 and day 7', 'description': "The general anxiety level associated with dental procedures was assessed through the Corah Dental Anxiety Scale (CDAS), which includes of four questions designed to evaluate the patient's dental anxiety level. The results were evaluated using a scoring system ranging from 4 (no anxiety) to 20 (high anxiety)."}], 'secondaryOutcomes': [{'measure': 'Salivary Cortisol Levels', 'timeFrame': 'Day 1 and day 7', 'description': "In evaluating the patients' stress levels through experimental and chemical tests, the method of measuring cortisol levels from salivary samples was preferred. The results were evaluated using a scoring system ranging from 1.4 (low salivary cortisol level) -10.1(high salivary cortisol level) ng/ml."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dental anxiety', 'salivary cortisol', 'dental anxiety scale'], 'conditions': ['Dental Anxiety']}, 'descriptionModule': {'briefSummary': "This study aimed to compare the stress levels induced in patients at the beginning and at the end of endodontic and restorative treatments and access relationship between dental anxiety levels and cortisol levels.\n\nFor this study, 44 patients requiring endodontic and restorative treatment on a maxillary premolar tooth were selected. Patients were requested to fill out the Corah Dental Anxiety Scale (CDAS) questionnaire prior to and following each treatment procedure. Saliva samples were then collected using the roll cotton method. The saliva was analysed by using the Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) method. Intragroup comparisons of CDAS and cortisol levels were conducted using the Wilcoxon Signed Rank Test. Intergroup comparisons were performed employing the Mann-Whitney U Test. The magnitude of the association between continuous variables was investigated by calculating Spearman's rank-order correlation coefficients along with corresponding significance levels (p\\< 0.05).", 'detailedDescription': "Anxiety is a psychological state defined as significant worry, fear, and tension in response to perceived threats, dangers, or uncertainties. A key long-term consequence of stress exposure is an increased release of cortisol, a hormone regulated by the activation of the hypothalamic-pituitary-adrenal (HPA) axis and the adrenal glands. Cortisol is integral to the body's stress response, with its levels increasing notably during episodes of anxiety, thereby triggering physiological changes.\n\nDental anxiety, specifically, refers to an intense fear and apprehension associated with dental treatments. This type of anxiety may be associated with several factors, such as negative dental experience, the nature of dental procedures, or individual perception of treatment. Moreover, demographic factors like socioeconomic status, sex, education, and age can impact the development of dental anxiety. Also, childhood experiences of traumatic dental treatments are another critical factor, often resulting in negative attitudes toward dental care.\n\nResearch shows that dental anxiety tends to peak during procedures involving injections, though other treatments like dental restorations, endodontic treatment, and tooth extractions are also major sources of distress. Various approaches are utilized to assess dental anxiety, including measuring cortisol levels, administering self-report questionnaires, and using pain rating scales. Commonly applied tools include the Spielberger State-Trait Anxiety Inventory (STAI), Corah's Dental Anxiety Scale (CDAS), Dental Fear Survey (DFS), and the Modified Dental Anxiety Scale (MDAS).\n\nThe null hypothesis proposes that endodontic and restorative procedures evoke similar anxiety levels in patients, with no significant association detected between salivary cortisol levels and CDAS measurements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants over 18 years old\n* Participants who are classified as ASA I according to the American Society of Anaesthesiologists (ASA) physical status classification system.\n* Patients who require root canal treatment and will have composite restoration afterwards.\n\nExclusion Criteria:\n\n* Patients with communication and cooperation problems.\n* Patients who take medication regularly.\n* Conditions such as Sjögren's syndrome or xerostomia, which affect salivary flow.\n* Pregnancy.\n* Patients with systemic diseases."}, 'identificationModule': {'nctId': 'NCT06764758', 'briefTitle': 'Anxiety Levels of Patients Subjected to Endodontic and Restorative Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Baskent University'}, 'officialTitle': 'Short-Term Clinical Comparison of Anxiety Levels With Salivary Cortisol Levels in Patients Undergoing Endodontic and Restorative Treatment', 'orgStudyIdInfo': {'id': 'D-KA23/28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endodontic treatment', 'description': 'gutta-percha (Sure Dent Corporation; Gyeonggi-do, Korea)', 'interventionNames': ['Procedure: Endodontic treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Restorative treatment', 'description': 'Composite resin restorative material (3M Espe Filtek; Lake County, Minnesota, USA)', 'interventionNames': ['Procedure: Restorative treatment']}], 'interventions': [{'name': 'Endodontic treatment', 'type': 'PROCEDURE', 'description': 'Root-canal therapy applied in asymptomatic teeth with deep carious lesion required endodontic treatment.', 'armGroupLabels': ['Endodontic treatment']}, {'name': 'Restorative treatment', 'type': 'PROCEDURE', 'description': 'Composite resin restoration applied in teeth previously applied endodontic treatment.', 'armGroupLabels': ['Restorative treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06490', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Baskent University Faculty of Dentistry, Ankara, Turkey', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Kamran Gulsahi, DDS., PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Baskent University Faculty of Dentistry'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after 6 months after article publication', 'ipdSharing': 'YES', 'description': 'The de-identified data will be made available by contacting the first author', 'accessCriteria': 'for research purposes by contacting the first author via e-mail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baskent University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}