Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-02-21 @ 1:34 AM
Study NCT ID:
NCT06682559
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-05
First Post:
2024-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Two Different Healing Abutments in Single Posterior Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Statistician'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2024-11-04', 'studyFirstSubmitQcDate': '2024-11-08', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of peri-implant soft tissues volume', 'timeFrame': '3 months', 'description': 'Each participant will undergo volumetric analysis of peri-implant soft tissues after 3 months healing either after using prefabricated healing abutment with scan peg in comparison to customized healing abutment using a 3D meteorology software (GOM inspect). It will be measured in millimeter cube'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental implants', 'single missing posterior teeth', 'peri-implant soft tissues'], 'conditions': ['Dental Implants', 'Dental Implants, Single-tooth']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized clinical trial is to evaluate the volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg in comparison to customized healing abutment.', 'detailedDescription': 'Volumetric analysis of peri-implant soft tissues after 3 months of the use of a prefabricated healing abutment with scan peg with convex emergence profile in comparison to customized healing abutment with concave emergence profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who are classified as ASA I or II physical status and require mandibular single implants (single missing mandibular posterior teeth) with:\n\n 1. Proper bone height and width.\n 2. Adequate zone of keratinized tissue (at least 2 mm)\n\nExclusion Criteria:\n\n* Any systematic disease as uncontrolled diabetes mellitus or metabolic bone diseases\n* Pregnancy and Lactation\n* A history of head and neck radiation treatment.\n* Chronic periodontal diseases.\n* Poor oral hygiene (Silness-Löe plaque index score 2 and 3)\n* Parafunctional habits.'}, 'identificationModule': {'nctId': 'NCT06682559', 'briefTitle': 'Comparison Between Two Different Healing Abutments in Single Posterior Implants', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Comparison of Two Different Healing Abutments in Single Posterior Implants: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '0991-10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prefabricated healing abutment with scan peg (Neoss implant system, Harrogate, England)', 'description': '12 participants will receive single posterior implants by fully guided implant protocol followed by placement of prefabricated healing abutment with scan peg having convex emergence profile', 'interventionNames': ['Other: Prefabricated healing abutment with scan peg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Customized healing abutment', 'description': '12 participants will receive single posterior implants by fully guided implant protocol followed by placement of custom healing abutment having concave emergence profile', 'interventionNames': ['Other: Customized healing abutment']}], 'interventions': [{'name': 'Prefabricated healing abutment with scan peg', 'type': 'OTHER', 'description': '12 participants will receive single posterior implants by fully guided implant protocol followed by placement of prefabricated healing abutment with scan peg having convex emergence profile', 'armGroupLabels': ['Prefabricated healing abutment with scan peg (Neoss implant system, Harrogate, England)']}, {'name': 'Customized healing abutment', 'type': 'OTHER', 'description': '12 participants will receive single posterior implants by fully guided implant protocol followed by placement of custom healing abutment having concave emergence profile', 'armGroupLabels': ['Customized healing abutment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University, Egypt', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Mervat E Abdellah', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Rania Elsayed', 'investigatorAffiliation': 'Alexandria University'}}}}