Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-06 @ 4:25 PM
Study NCT ID:
NCT02845193
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2016-07-19', 'studyFirstSubmitQcDate': '2016-07-22', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Parents' satisfaction", 'timeFrame': '3 months', 'description': 'It will be assessed using Questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Nasal Esthetics: a- Nostril height', 'timeFrame': '3 months', 'description': 'It will be measured in mm by Digital ruler on the images using a software.'}, {'measure': 'Nasal Esthetics: b- Nostril width', 'timeFrame': '3 months', 'description': 'It will be measured in mm by Digital ruler on the images using a software.'}, {'measure': 'Nasal Esthetics: c- Nasal sill height', 'timeFrame': '3 months', 'description': 'It will be measured in mm by Digital ruler on the images using a software.'}, {'measure': 'Nasal Esthetics: d- Nostril area', 'timeFrame': '3 months', 'description': 'It will be measured on the images in mm 2 (square) using a software measuring area.'}, {'measure': 'Interlabial gap', 'timeFrame': '3 months', 'description': 'It will be measured in mm by Digital ruler on the images using a software.'}, {'measure': 'Maxillary Arch Dimension', 'timeFrame': '3 months', 'description': 'It will be measured as distances in mm between landmarks identified on the dental models assessing the anterioposterior, transverse and vertical changes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cleft Lip and Palate']}, 'referencesModule': {'references': [{'pmid': '36126199', 'type': 'DERIVED', 'citation': 'Abd El-Ghafour M, Aboulhassan MA, El-Beialy AR, Fayed MMS, Eid FHK, Emara D, El-Gendi M. Does Presurgical Taping Change Nose and Lip Aesthetics in Infants with Unilateral Cleft Lip and Palate? A Randomized Controlled Trial. Plast Reconstr Surg. 2022 Dec 1;150(6):1300e-1313e. doi: 10.1097/PRS.0000000000009738. Epub 2022 Sep 20.'}]}, 'descriptionModule': {'briefSummary': "The aim of this trial is to figure out the efficiency of modified Grayson NAM on parents' satisfaction, nasal esthetics, interlabial gap and maxillary arch changes. NAM might improve and facilitate the surgical procedure after lip closure. This might decrease the need of further interventions to improve esthetics and function of CLP patients. This trial will help the patients and practitioners in taking the decision of inclusion of NAM in the CLP treatment protocol as a mandatory step or skip a useless procedure with all of its burden.", 'detailedDescription': "In this randomized trial, 4 groups will be included. The first group will receive a modified nasoalveolar molding appliance in addition to taping. In the second group, the patient will receive the CAD/NAM. the third group is tape only, while the fourth group remain untreated. the follow-up period will be 3 months till surgical lip closure. the assessment will be through a questionnaire for the parents' satisfaction outcome, photographs for nasal esthetics and interlabial gap outcome and maxillary models for the maxillary dimension change outcome."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '30 Days', 'minimumAge': '7 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Infants with age range from 7 - 30 days.\n2. Unilateral complete cleft lip and alveolus.\n3. Presence of unilateral cleft palate.\n4. Medically free subjects.\n5. Both males and females.\n\nExclusion Criteria:\n\n1. Patients older than 30 days.\n2. Syndromic patients with other defects in addition to cleft lip and palate.\n3. Patients with bilateral cleft lip and palate.\n4. Incomplete Cleft lip.\n5. Medically compromised patients.'}, 'identificationModule': {'nctId': 'NCT02845193', 'briefTitle': "Effect of Novel Nasoalveolar Molding Techniques on Parents' Satisfaction and Short Term Treatment Outcomes in Unilateral Cleft Lip and Palate Infants: A Randomized Controlled Trial", 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': "Effect of A Novel (Modified Grayson) Technique for Nasoalveolar Molding and Taping on Parents' Satisfaction and Short Term Treatment Outcomes in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'CEBD-2016-07-172'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Nasoalveolar molding group', 'description': 'This group will receive nasoalveolar molding appliance in addition to taping for 3 Months with follow-up every 2 weeks.', 'interventionNames': ['Device: Modified Nasoalveolar molding']}, {'type': 'EXPERIMENTAL', 'label': 'Taping group', 'description': 'Tape will be used alone in this group on the upper lip segments for 3 months with follow-up every 2 weeks.', 'interventionNames': ['Device: Taping']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This group will not receive any treatment.'}, {'type': 'EXPERIMENTAL', 'label': 'CAD/NAM group', 'description': 'Computer Aided Designed Nasoalveolar molding and 3D printed.', 'interventionNames': ['Device: CAD/NAM']}], 'interventions': [{'name': 'Modified Nasoalveolar molding', 'type': 'DEVICE', 'description': "Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).", 'armGroupLabels': ['Modified Nasoalveolar molding group']}, {'name': 'Taping', 'type': 'DEVICE', 'description': 'Infants will receive a tape only on the upper lip segments to mold it to touch each other.', 'armGroupLabels': ['Taping group']}, {'name': 'CAD/NAM', 'type': 'DEVICE', 'description': 'computer aided design NAM', 'armGroupLabels': ['CAD/NAM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00202', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Mohamed Abd El-Ghafour', 'investigatorAffiliation': 'Cairo University'}}}}