Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT06364020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2024-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Risk Factors in Patients With Non-carious Cervical Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D005889', 'term': 'Gingival Recession'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D002012', 'term': 'Bruxism'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D006184', 'term': 'Habits'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-09', 'studyFirstSubmitDate': '2024-04-09', 'studyFirstSubmitQcDate': '2024-04-09', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate the association between anxiety/stress and the presence of NCCL.', 'timeFrame': 'During inclusion visit', 'description': 'Assessment questionnaire DASS21 (Depression Anxiety Stress (DASS-21 ; Lovibond \\& Lovibond, 1995).'}], 'secondaryOutcomes': [{'measure': 'To investigate the association between bruxism and the presence of NCCL.', 'timeFrame': 'During inclusion visit', 'description': 'SCOFF Questionnaire (Kutz et al. 2020)'}, {'measure': 'To investigate the association between eating disorders and the presence of NCCL.', 'timeFrame': 'During inclusion visit', 'description': 'Bruxism questionnaire (Khoury \\& al. 2016)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Periodontics', 'Anxiety,', 'Gingival recession', 'Feeding and Eating disorders', 'Bruxism', 'Restorative dentistry', 'NonCarious Cervical Lesions'], 'conditions': ['Anxiety', 'Stress', 'Non-carious Cervical Lesions']}, 'descriptionModule': {'briefSummary': 'In the management of patients with noncarious cervical lesions (NCCL), we observe that they frequently present signs of anxiety, traumatic brushing, bruxism or eating disorders. These multifactorial and interrelated etiologies make diagnosis and management difficult. Furthermore, in the literature, there is a lack of studies that evaluate the relationship between these risk factors and NCCL. A better understanding of the etiology and risk factors would help to optimize patient management and direct patients to the most appropriate therapies.', 'detailedDescription': 'Tooth wear is a cumulative loss of surface area at the expense of mineralized tooth tissue caused by physical or physicochemical processes (erosion, attrition, abrasion), i.e., excluding carious lesion, resorption, or trauma.\n\nNon-carious cervical lesions (NCCL) correspond to hard tissue loss in the cervical area of the tooth by processes not related to caries.\n\nThe prevalence of NCCL varies between 5 and 85% depending on the study and the severity of cervical wear increases with age. A 2020 systematic review estimates the prevalence of NCCL at 46.7%.\n\nNCCL are frequent pathologies caused by changes in lifestyle and diet. The reasons for consultation are diverse and varied, either symptomatic (sensitivities) functional (food retention) or aesthetic. The prevalence and severity of wear increases with age. It is generally accepted that lesions are not generated by a single factor but result from a combination of factors, such as erosion, abrasion or abfraction. The clinical appearance of NCCLs may vary depending on the type and severity of the etiologic factors involved. Proper diagnosis of this type of lesion requires a comprehensive knowledge of the different etiologies as well as their multifactorial aspects through focused questioning and careful clinical observation. Due to the multifactorial and interrelated etiologies, accurate diagnosis of NCCLs is challenging.\n\nPrevention and proper management of NCCL requires an understanding of the etiology and risk factors related to mental disorders such as depression, stress and anxiety or pathological behaviors such as traumatic brushing or bruxism. Wear lesions can be aggravated by gastroesophageal reflux and eating disorders resulting from mental disorders that are devastating to dental tissue. The decision to monitor NCCLs rather than intervene should be based on the progression of the lesions and how they compromise the vitality, function, and aesthetics of the teeth.\n\nDuring the management of patients with NCCL, we observe that they show signs of anxiety. Therefore, the objective is to assess the level of anxiety in patients with NCCL and to compare it to that of patients without NCCL.\n\nWe wish to carry out an observational survey from a prospective cohort at the Rothschild Hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult patients seen in specialized periodontology consultation at Rothschild Hospital.\n\nDuring the initial consultation, according to current protocol and practice, the practitioner performs a complete examination of the mouth and teeth and indicates in the patient's medical record the possible presence of oral pathologies, including the diagnosis of NCCL.\n\nThe presence of NCCL is judged on all teeth and defined by the presence of 4 or more NCCLs with a depth (buccolingual) and height (occlusogingival) greater than or equal to 2 mm.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: between 18 and 60 years old;\n* Specialized periodontal consultation.\n\nExclusion Criteria:\n\n* Patients with co-morbidities that do not allow for adequate brushing of the teeth (Parkinson, Alzheimer...);\n* Patients with removable prothesis for two years or more;\n* Patients under guardianship or trusteeship.'}, 'identificationModule': {'nctId': 'NCT06364020', 'acronym': 'LACIS', 'briefTitle': 'Assessment of Risk Factors in Patients With Non-carious Cervical Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Assessment of Risk Factors in Patients With Non-carious Cervical Lesions', 'orgStudyIdInfo': {'id': 'APHP230067'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adult patients seen in specialized periodontology consultation at Rothschild Hospital', 'description': 'The population that will be studied will be patients received in the first specialized clinical periodontology consultation aged between 18 and 60 years.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Caroline Mocquot, MCU-PH', 'role': 'CONTACT', 'email': 'caroline.mocquot@aphp.fr', 'phone': '+33622971627'}, {'name': 'Maria Clotilde Carra, Professor', 'role': 'CONTACT', 'email': 'mariaclotilde.carra@aphp.fr', 'phone': '+33630746555'}], 'facility': 'Hôpital Rothschild - Service Odontologie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Caroline Mocquot, MCU-PH', 'role': 'CONTACT', 'email': 'caroline.mocquot@aphp.fr', 'phone': '+33622971627'}, {'name': 'Maria Clotilde Carra, Professor', 'role': 'CONTACT', 'email': 'mariaclotilde.carra@aphp.fr', 'phone': '+33630746555'}], 'overallOfficials': [{'name': 'Caroline Mocquot, MCU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}