Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 1:57 PM
Study NCT ID:
NCT04281056
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2020-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Tooth Loss and Denture on Oral Senses and Food Preferences
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000848', 'term': 'Anodontia'}], 'ancestors': [{'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014081', 'term': 'Tooth Extraction'}], 'ancestors': [{'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2020-02-20', 'studyFirstSubmitQcDate': '2020-02-20', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'taste detection thresholds', 'timeFrame': 'up to 30 days', 'description': 'Using an Electrogustometer'}], 'secondaryOutcomes': [{'measure': 'Chemical taste identification ability', 'timeFrame': 'up to 30 days', 'description': 'Using taste strips (Burghard)'}, {'measure': 'Quantitative sensory testing', 'timeFrame': 'up to 30 days', 'description': 'Using an algometer, von frey filament, a thermode.'}, {'measure': 'Food preferences and selectivity', 'timeFrame': 'up to 30 days', 'description': 'Questionnaire food selectyivity and preference (Maitre et al., 2014)'}, {'measure': 'Taste appetence', 'timeFrame': 'up to 30 days', 'description': 'Questionnaire PrefQuest (Deglaire et al., 2012)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Teeth loss', 'edentulousness', 'denture', 'tast', 'trigeminal senses', 'oral sensory ability'], 'conditions': ['Tooth-loss']}, 'descriptionModule': {'briefSummary': 'Tooth loss impacts taste abilities and food intake. Present study aims at pertaining the impact of teeth loss and the replacement by means of complete denture on taste and trigeminal abilities, and on food preferences, and taste appetence.', 'detailedDescription': 'Two groups of participants will be included. Participants wearing complete denture for at least one year (n=20) and their matched controls for age, sex, tobacco, and saliva secretion (n=20). Their oral sensory abilities of participants will be assessed including taste (electrogustometric thresholds, chemical taste identification ability) and trigeminal quantitative sensory testing. Food preferences and selectivity (Maitre et al., 2014) and taste appetence (Deglaire et al., 2012) will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nStudy Group : being completely edentulous and wearing denture for at least one year, wearing denture during meals, with clean and stable dentures. Controls:\n\ncontrols Group : dentate subjects (25 teeth at leas, non endodontically treated) with molars in Angle's Class I occlusion, having no functional disturbance of mastication and not undergoing dental treatment at the time of the recording. Matched with subjects of the study group for age, sex, tabacco consumption, and saliva flow rate.\n\nExclusion Criteria:\n\n* Aged under 18 or over 80 Y,\n* not consenting to participate\n* suffering from dental\n* periodontal or gum pain for the last month."}, 'identificationModule': {'nctId': 'NCT04281056', 'acronym': 'AlimaPAC', 'briefTitle': 'Impact of Tooth Loss and Denture on Oral Senses and Food Preferences', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Impact of Complete Tooth Loss and Denture on Oral Sensory Abilities and Food Preference', 'orgStudyIdInfo': {'id': 'APHP190340'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'EXPERIMENTAL', 'label': 'Tooth removal', 'description': 'Tooth removal and their replacement by means of a denture Teeth have been removed and replaced by means of dentures for at least one year', 'interventionNames': ['Procedure: Tooth removal and their replacement by means of a denture']}], 'interventions': [{'name': 'Tooth removal and their replacement by means of a denture', 'type': 'PROCEDURE', 'description': 'Teeth have been removed and replaced by means of dentures for at least one year', 'armGroupLabels': ['Tooth removal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75002', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Adeline Braud, Dr', 'role': 'CONTACT', 'email': 'adeline.braud@aphp.fr', 'phone': '01 40 19 39 87'}], 'facility': 'Service odontologie Hôpital Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Adeline Braud, Doctor', 'role': 'CONTACT', 'email': 'adeline.braud@aphp.fr', 'phone': '01 40 19 39 87'}, {'name': 'Yves Boucher, Professor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Adeline Braud, Doctor', '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'}}}}