Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
Study NCT ID:
NCT03686761
Status:
COMPLETED
Last Update Posted:
2018-10-02
First Post:
2018-09-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Periodontal Changes Following Mid Maxillary Distraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}, {'id': 'D010514', 'term': 'Periodontal Pocket'}, {'id': 'D017622', 'term': 'Periodontal Attachment Loss'}, {'id': 'D007249', 'term': 'Inflammation'}], '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'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D055093', 'term': 'Periodontal Atrophy'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The clinical assessment was not masked , however, the histological and biomarker examination were send to blind investigator not directly involved in the study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Surgical distraction was performed in 20 cleft lip and palate (CLP) subjects with class III malocclusion, gingival GCF were collected from teeth neighboring the osteotomy site and from premolars of the opposite arch as control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-29', 'studyFirstSubmitDate': '2018-09-25', 'studyFirstSubmitQcDate': '2018-09-25', 'lastUpdatePostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluating the gingival histological changes', 'timeFrame': '2 and 4 weeks', 'description': 'histological examination of the soft tissue'}], 'primaryOutcomes': [{'measure': 'Measurement of periodontal inflammatory mediators', 'timeFrame': '7 days', 'description': 'periodontal inflammatory mediators IL-1β'}], 'secondaryOutcomes': [{'measure': 'Measurement of periodontal inflammatory mediators TNF- α', 'timeFrame': '7 days', 'description': 'periodontal inflammatory mediators TNF- α'}, {'measure': 'Assessment of periodontal probing depth', 'timeFrame': '3 and 6 month', 'description': 'probing depth measurement'}, {'measure': 'Assessment of clinical attachment loss', 'timeFrame': '3 and 6 month', 'description': 'clinical attachment loss measurement'}, {'measure': 'Assessment of periodontal clinical parameters', 'timeFrame': '3 and 6 month', 'description': 'Gingival index evaluation GI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammation', 'Healing', 'Distraction', 'Periodontium'], 'conditions': ['Cleft Lip and Palate', 'Periodontal Pocket', 'Attachment Loss, Periodontal']}, 'descriptionModule': {'briefSummary': 'To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).', 'detailedDescription': 'Segmental forward maxillary distraction osteogenesis(DO)was performed. Distractor connecting buccal molar segments to the anterior maxilla was kept for 7 days. Then distraction was performed till overcorrection and consolidated for 3-months. Periodontal clinical parameters were recorded at baseline, 3 and 6-months postoperatively. Gingival crevicular fluid was collected . Soft tissue healing was evaluated clinically and histologically after distraction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe maxillary hypoplasia and negative anterior overjet\n\nExclusion Criteria:\n\n* Systemic disease'}, 'identificationModule': {'nctId': 'NCT03686761', 'briefTitle': 'Periodontal Changes Following Mid Maxillary Distraction', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Periodontal Changes and Gingival Soft Tissue Healing Following Mid Maxillary Distraction in Cleft Lip and Palate Patients', 'orgStudyIdInfo': {'id': '00010556'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study', 'description': 'A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the', 'interventionNames': ['Procedure: A Involvement with the osteotomy site of the surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site', 'interventionNames': ['Procedure: A Involvement with the osteotomy site of the surgery']}], 'interventions': [{'name': 'A Involvement with the osteotomy site of the surgery', 'type': 'PROCEDURE', 'description': 'A Involvement with the osteotomy site of the surgery', 'armGroupLabels': ['Control', 'Study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21221', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Marwa Madi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alexandria', 'class': 'OTHER'}, 'collaborators': [{'name': 'Alexandria University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Marwa Ibrahim Madi', 'investigatorAffiliation': 'University of Alexandria'}}}}