Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2026-04-23 @ 4:56 PM
Study NCT ID:
NCT04906161
Status:
UNKNOWN
Last Update Posted:
2021-05-28
First Post:
2021-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-26', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implant success with normal serum vitamin D level', 'timeFrame': '6 months', 'description': 'Implant stability with no further radiographic bone loss following bone remodeling with successful prosthetic part'}, {'measure': 'Early implant failure with deficient serum vitamin D level', 'timeFrame': '6 months', 'description': 'Mobile extruded implant with radiographic bone loss and peri-implant pathosis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency', 'Dental Implant Failure Nos']}, 'descriptionModule': {'briefSummary': 'In this study there is a trial to investigate whether there is a correlation between early implant failure and low serum levels of vitamin D.', 'detailedDescription': 'Osseointegration is a complex phenomenon and depends on many factors; some are related to the implant (material, macroscopic design, and implant surface), others to the surgical-prosthetic protocol (surgical technique, loading conditions, and time), and others to the patient (quantity/quality of bone at the receiving site and the host response)\n\nAll these observations would suggest the existence of specific patient-related risk factors such as vitamin D deficiency in the blood, could play an important role in the occurrence of early dental implant failures (EDIFs), but unfortunately are neglected by the dental literature.\n\nIn this study there is a trial to investigate whether there is a correlation between early implant failure and low serum levels of vitamin D. Therefore we are including patients with early implant failure during the year 2020 using the same implant (material, macroscopic design, and implant surface), surgical-prosthetic protocol (surgical technique, loading conditions, and time)\n\nThe study will be performed into 15 male and 15 female participants that had dental implant placement in the last 3 months. An informed consent will be signed with the patient with full detail on the study.\n\nThe situation of the implant will be categorized into either successful or failed dental implant.\n\nMedical history and lifestyle information will be obtained by questionnaire. Levels of serum vitamin D will be collected from participants\n\nStatistical analysis will correlate between vitamin D and early implant failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Multicenter study on systemically free participants that had a dental implant within the last 6 months using the same implant system, preoperative planning techniques, surgical protocol (minimal invasive implant concept), post surgical protocol and excluding any cases with intrasurgical difficulties and complications.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Missing single tooth\n* Systemically free\n* Average body mass index\n\nExclusion Criteria:\n\n* Systemic conditions\n* Bad oral hygiene'}, 'identificationModule': {'nctId': 'NCT04906161', 'briefTitle': 'Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Correlation Between Vitamin D and Serum Calcium Level Insufficiency and Early Dental Implant Failure', 'orgStudyIdInfo': {'id': '1388'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Successful dental implant', 'description': 'Patients showed a successful implant placement with no complications before loading', 'interventionNames': ['Diagnostic Test: Vitamin D and calcium levels']}, {'label': 'Early dental implant failure', 'description': 'Early complications and failure of dental implant before loading', 'interventionNames': ['Diagnostic Test: Vitamin D and calcium levels']}], 'interventions': [{'name': 'Vitamin D and calcium levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'Mini VIDAS® compact multiparametric immunoanalyzer for vitamin D analysis (BIOMERIEUX- France)', 'armGroupLabels': ['Early dental implant failure', 'Successful dental implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Abbassia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Doaa Adel-Khattab, PhD', 'role': 'CONTACT', 'email': 'dr.doaa.adel-khattab@dent.asu.edu.eg', 'phone': '+201006814258'}, {'name': 'Mohamed S El-Mofty, PhD', 'role': 'CONTACT', 'email': 'mofty@dr.com', 'phone': '+201001431000'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '11566', 'city': 'Cairo', 'state': 'Abbassia', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Doaa Khattab', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Doaa Adel-Khattab, PhD', 'role': 'CONTACT', 'email': 'dr.doaa.adel-khattab@dent.sasu.edu.eg', 'phone': '+201006814258'}], 'overallOfficials': [{'name': 'Bassem E Abd ElMoneim Hussein, MDs', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Doaa Adel Salah Khattab', 'investigatorAffiliation': 'Ain Shams University'}}}}