Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-01 @ 3:34 PM
Study NCT ID:
NCT04559802
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2020-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016388', 'term': 'Tooth Loss'}], 'ancestors': [{'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2020-09-06', 'studyFirstSubmitQcDate': '2020-09-16', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hard tissue healing around dental implants', 'timeFrame': '4 months', 'description': 'bone healing around Submerged and Non-submerged dental implants will be measured by Periodontal probe and radiographs. A Mann-Whitney U Test will be used to calculate bone healing changes. To evaluate bone healing Mean values, standard deviations and frequencies will be calculated.'}], 'secondaryOutcomes': [{'measure': 'Soft tissue healing around dental implants', 'timeFrame': '4 months', 'description': "Soft tissue healing around Submerged and Non-submerged dental implants. Fisher's exact test will be used to evaluate soft tissue healing changes through analyzing the measurements obtained by periodontal probe and radiographs."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tooth Loss']}, 'descriptionModule': {'briefSummary': 'It is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation.', 'detailedDescription': 'Implants receiving Contour Augmentations at the time of placement are randomized into two groups, submerged and non submerged. Healing is evaluated at 4 months post op compared to the day of surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age more than 21 years - ASA I or II.\n* Patient's willingness to participate in this study.\n* Availability for 4-month follow-up.\n* Absence of active periodontal disease.\n* Single tooth replacement is needed with simultaneous contour augmentation.\n* Available pre-operative CBCT study.\n* Extraction of tooth at least 8 weeks prior to planned implant therapy.\n\nExclusion Criteria:\n\n* Pregnancy at the screening visit.\n* Smoking more than 10 cig/day.\n* Active infection at the site of surgery (teeth involved).\n* Multiple missing teeth adjacent to each other (long span edentulous area).\n* Vertical bone defect less than 2mm (intra surgical assessment)"}, 'identificationModule': {'nctId': 'NCT04559802', 'briefTitle': 'Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation', 'organization': {'class': 'OTHER', 'fullName': 'Nova Southeastern University'}, 'officialTitle': 'Submerged Versus Non-Submerged Healing of Implants Subjected to Contour Augmentation.', 'orgStudyIdInfo': {'id': '2020-341'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transmucosal (Non-Submerged)', 'description': 'Flaps will be adapted to the healing abutments for a trans-mucosal healing up on closure', 'interventionNames': ['Procedure: Transmucosal Technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Submerged', 'description': 'Flaps will be advanced to achieve primary wound closure.', 'interventionNames': ['Procedure: Submerged Technique']}], 'interventions': [{'name': 'Transmucosal Technique', 'type': 'PROCEDURE', 'otherNames': ['Non-submerged technique'], 'description': 'Dental implant will be placed in transmucosal manner (Healing abutment is exposed in the mouth).', 'armGroupLabels': ['Transmucosal (Non-Submerged)']}, {'name': 'Submerged Technique', 'type': 'PROCEDURE', 'description': 'Dental implant will be installed in submerged manner (implant is completed covered by soft tissue).', 'armGroupLabels': ['Submerged']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33314', 'city': 'Davie', 'state': 'Florida', 'country': 'United States', 'facility': 'Nova South Eastern university', 'geoPoint': {'lat': 26.06287, 'lon': -80.2331}}], 'overallOfficials': [{'name': 'Stavros Sofos, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Southeastern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Southeastern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Theofilos Koutouzis', 'investigatorAffiliation': 'Nova Southeastern University'}}}}