Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-05 @ 6:23 PM
Study NCT ID:
NCT03536468
Status:
UNKNOWN
Last Update Posted:
2019-11-15
First Post:
2018-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Impact of Tooth Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}, {'id': 'D016388', 'term': 'Tooth Loss'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 145}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2018-04-13', 'studyFirstSubmitQcDate': '2018-05-14', 'lastUpdatePostDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hospital anxiety and depression (HAD) score', 'timeFrame': '1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)', 'description': 'The HADS is a 14-item self-assessment scale designed to evaluate emotional stress induced by chronic pain in non-psychiatric populations. HAD-A assessed anxiety and HAD-D evaluated depression. Scores of greater than 10 were indicative of anxiety or depression, scores of 7 or less were indicative of no significant anxiety and depression, and scores of 8 to 10 indicated borderline anxiety or depression.'}], 'secondaryOutcomes': [{'measure': 'Change in General oral health assessment index (GOHAI)', 'timeFrame': '1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)', 'description': 'The General oral health assessment index (GOHAI) is a questionnaire about the impact of oral health on quality of life. It includes 12 items evaluating three dimensions of oral health with respect to quality of life: (1) functional field (eating, speaking, and swallowing); (2) psychological field (appearance, social relationship); (3) pain or discomfort concerning gums or teeth. Each item has a score ranging from 1 to 5. The GOHAI-add score corresponds to the sum of the scores and ranges from 12 to 60 (20 for functional field, 25 for psychological field, and 15 for comfort/pain field). A score higher than 57 is high and indicates a satisfactory oral quality of life. A score from 51 to 56 is average and a score of 50 or less is low, reflecting a poor oral quality of life.'}, {'measure': 'Gender', 'timeFrame': 'at date of inclusion (up to 24h)', 'description': 'Respondents complete a questionnaire identifying their gender (man or woman)'}, {'measure': 'Age', 'timeFrame': 'at date of inclusion (Up to 24h)', 'description': 'Respondents complete a questionnaire identifying their age (in years)'}, {'measure': 'Educational level', 'timeFrame': 'at date of inclusion (Up to 24h)', 'description': 'Respondents complete a questionnaire identifying their educational level : last degree (no degree at al, French General Certificate Secondary Education, High School Diploma, Vocational Training Certificate taken at Secondary School, university degree)'}, {'measure': 'Income', 'timeFrame': 'at date of inclusion (Up to 24h)', 'description': 'Respondents completed a questionnaire identifying their income level each month (in euros)'}, {'measure': 'General health', 'timeFrame': 'at date of inclusion (Up to 24h)', 'description': 'Respondents complete a questionnaire indentifying their general heath and the existence of disease'}, {'measure': 'Dental status', 'timeFrame': 'at date of inclusion (Up to 24h)', 'description': 'Dental Examination is done by a dental practioner'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tooth loss, edentulousness, psychology, oral health-related'], 'conditions': ['Edentulous Mouth', 'Partial Edentulism']}, 'descriptionModule': {'briefSummary': 'Tooth loss impact on daily living, mood and self-perceived well-being. However, psychological impact of teeth loss has not been evaluated. Present study aims to evaluate the psychological conditions of patients pending complete tooth extraction before and shortly after tooth loss using Hospital Anxiety and Depression scale (HAD) and Geriatric Oral Health Assessment Index (GOHAI).', 'detailedDescription': 'Patients will be interviewed concerning their psychological conditions (HADS) and their oral health related quality of life (GOHAI) before tooth extraction and one month after complete tooth loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients pending complete tooth extraction within the groupe hospitalier Pitie Salpétrière', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* willing to participate to the study\n* dental status identified\n\nExclusion Criteria:\n\n* uncooperative ou patient not able to complete the questionary\n* adult patients under protection'}, 'identificationModule': {'nctId': 'NCT03536468', 'acronym': 'Edentpsy', 'briefTitle': 'Psychological Impact of Tooth Loss', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Short Term Psychological Impact of Tooth Loss in Patients Consulting in a University Dental Clinic', 'orgStudyIdInfo': {'id': 'NI17037J'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients pending complete tooth loss', 'description': 'Will be recruited patients pending tooth loss, ages between 18 and 65 years, whose dental conditions have previously been identified'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75002', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Adeline Braud, Dr', 'role': 'CONTACT'}], 'facility': 'Pôle odontologie Hôpital Rothschild', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Adeline Braud', 'role': 'CONTACT', 'email': 'adeline.braud@aphp.fr', 'phone': '01 40 19 39 87'}, {'name': 'Yves Boucher', 'role': 'CONTACT', 'email': 'yves.boucher@univ-paris-diderot.fr', 'phone': '01 44 27 81 23'}], 'overallOfficials': [{'name': 'Adeline Braud', 'role': 'STUDY_DIRECTOR', 'affiliation': 'APHP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}