Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04049058
Status:
UNKNOWN
Last Update Posted:
2020-11-20
First Post:
2019-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002972', 'term': 'Cleft Palate'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-19', 'studyFirstSubmitDate': '2019-08-01', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of the OQLQ (Orthognathic Quality of Life Questionnaire) questionnaire score between the preoperative assessment and at 6 months postoperatively.', 'timeFrame': 'between the preoperative assessment and at 6 months postoperatively.', 'description': 'The OQLQ questionnaire is composed of 22 items that can be rated from 0 to 4. The score varies from 0 to 88. This questionnaire is specific to the evaluation of quality of life in relation to orthognathic surgery.'}], 'secondaryOutcomes': [{'measure': 'Change of OHIP-14 questionnaire score (Oral Health Impact Profile) between preoperative evaluation and at 6 months postoperatively.', 'timeFrame': 'between the preoperative assessment and at 6 months postoperatively.', 'description': 'The questionnaire is a non-specific questionnaire assessing quality of life in relation to general oral health. It is composed of 14 questions that can be scored from 0 to 4. The score varies from 0 to 56.'}, {'measure': 'Change of OQLQ (Orthognathic Quality of Life Questionnaire) by type of orthognathic surgery', 'timeFrame': 'at 6 months', 'description': 'the type of orthognathic surgery performed = monomaxillary versus bimaxillary'}, {'measure': 'Change of OHIP-14 (Oral Health Impact Profile) by type of orthognathic surgery', 'timeFrame': 'at 6 months', 'description': 'the type of orthognathic surgery performed = monomaxillary versus bimaxillary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Palate, Cleft']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare, prospectively, the quality of life of patients with cleft lip and palate before and after orthognathic surgery. This is done through two validated questionnaires: OHIP-14 (Oral Health Impact Profile) and OQLQ (Orthognathic Quality of Life Questionnaire) Improving the quality of life is the goal of any functional treatment. The demonstration of its improvement would validate the validity of this additional surgery for patients with cleft lip and palate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with cleft lip and palate with malocclusion and indication of orthognathic surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man and woman ; Age: adolescents (12-17 years) and adults; Specific medical conditions: cleft lip and palate, malocclusion\n* Non-opposition of the patient\n* Patient willing to comply with all procedures of the study and its duration\n\nExclusion Criteria\n\n* Cancellation of orthognathic surgery\n* Impossibility to receive enlightened information, impossibility to participate in the totality of the study, impossibility to complete only the questionnaire'}, 'identificationModule': {'nctId': 'NCT04049058', 'acronym': 'ORTHOQOL', 'briefTitle': 'Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context', 'orgStudyIdInfo': {'id': '2018_55'}, 'secondaryIdInfos': [{'id': '2018-A03376-49', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Hôpital Roger Salengro, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Romain Nicot, MD', 'role': 'CONTACT', 'email': 'romain.nicot@chru-lille.fr', 'phone': '0320446360', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Romain Nicot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}