Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT06702969
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2024-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2024-11-03', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pink esthetic score', 'timeFrame': 'at the baseline(time of impression), second time was one week later (immediately) after crown placement, third time was one month later after crown placement , fourth time was three months later after crown placement', 'description': 'The pink esthetic score is based on seven variables:\n\n* Mesial papilla\n* Distal papilla\n* Soft-tissue level\n* Soft- tissue contour\n* Alveolar process deficiency\n* Soft-tissue color and texture Each variable was assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score'}, {'measure': 'marginal bone loss', 'timeFrame': 'immediately after crown placement (baseline), then three months after crown placement', 'description': 'described by millimeter using paralleling technique'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': 'after crown placement', 'description': 'satisfaction questionnaire modified from based on 10 specific questions.\n\nThe questions were as follows:\n\n1. Are you satisfied with the treatment? with 0 = very dissatisfied and 100 = very satisfied\n2. Did you experience discomfort during the impression-taking? with 0 = high discomfort and 100 = no discomfort\n3. Did you experience gag reflex/nausea during the impression-taking? with 0 = strong gag reflex/nausea, and 100 = no gag reflex/nausea\n4. How comfortable was the impression procedure? with 0 = uncomfortable and 100 = comfortable\n5. Does your implant-supported restoration function well? with 0 = bad function and 100 = well function'}, {'measure': 'plaque index', 'timeFrame': 'Immediately after crown placement (baseline), one months later , and finally three months after crown placement', 'description': '0 = No plaque in gingival area.\n\n1. = A film of plaque adhering to the free gingival margin and adjacent area of tooth. The plaque may be recognized only by running a probe across the tooth surface.\n2. = Moderate accumulation of soft deposit within the gingival pocket and on the gingival pocket and on the gingival margin and/or adjacent tooth surface that can be seen by naked eye.\n3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.\n\n * of sites positive for dental plaque will be calculated for each case.'}, {'measure': 'gingival index', 'timeFrame': 'Immediately after crown placement (baseline), one months later , and finally three months after crown placement', 'description': '0 = Normal gingiva.\n\n1. = Mild inflammation, slight change in color, slight edema; no bleeding on probing.\n2. = Moderate inflammation, redness, edema, and glazing; bleeding on probing.\n3. = Sever inflammation, marked redness and edema, ulceration; tendency to spontaneous bleeding.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate implant', 'Digital impression', 'Pink esthetic score', 'Conventional impression'], 'conditions': ['Patient Satisfaction']}, 'descriptionModule': {'briefSummary': "This randomized controlled clinical study will be carried out to compare the digital with conventional impression procedures for the restoration of single implants in an esthetic zone by assessing:\n\n1. pink esthetic score (PES) of peri-implant soft tissue profile and marginal bone loss (MBL) as primary objectives\n2. Patients' satisfaction and clinical outcomes as secondary objectives", 'detailedDescription': 'fourteen patients with single nonrestorable tooth in the esthetic zone participated in the study and were replaced with immediate implants with immediate customized provisional restoration after 3 months they recalled for the impression, seven with digital and the others with conventional and evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Both genders within age range of 20-50 years.\n2. Systemically healthy participants classified as American Society of Anesthesiologists( ASA ) class I . Guided by medical questionnaire modified from Burkett's\n3. Single non restorable tooth in upper anterior esthetic zone with at least 4 mm bone present apical to the root apex for primary stability.\n4. Type I extraction sockets according to classification.\n5. Ability to attend the surgery , comply to it's procedures , the recall visits and oral hygiene protocol .\n6. Thick gingival phenotype with thickness ≥ 2 mm around the non-restorable tooth -\n\nExclusion Criteria:\n\n1. Missing adjacent teeth or opposing tooth. .\n2. Acute periapical pathosis or active periodontal infections related to non-restorable tooth or adjacent teeth.\n3. Smokers.\n4. Pregnant or lactating females.\n5. Patients with para-functional habits (bruxism and/or clenching)\n6. Vulnerable groups (handicapped, orphans, and prisoners). -"}, 'identificationModule': {'nctId': 'NCT06702969', 'briefTitle': 'Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Influence of Digitalized Impression on Single Peri-implant Soft Tissue Profile in Esthetic Zone and Patient Satisfaction: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Digitalized Impression'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Digital impression with intraoral scanner', 'description': 'included seven participants with non-restorable tooth in esthetic zone replaced by immediate implants receiving a single all ceramic crown fabricated with full digital procedure consisting of digital impression with intraoral scanner, and Computer Aided Design/ Computer Aided Manufacture (CAD/CAM) procedure.', 'interventionNames': ['Device: Intra oral scanner']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional impression technique', 'description': 'included seven participants with non-restorable tooth in esthetic zone replaced by immediate implants receiving a single all ceramic crown fabricated with Conventional impression-taking with polyvinyl siloxane, plaster model pouring and lost-wax casting technique', 'interventionNames': ['Device: impression analog']}], 'interventions': [{'name': 'Intra oral scanner', 'type': 'DEVICE', 'otherNames': ['implant placement'], 'description': 'Immediate implant placement with customized healing abutment and after three months placement all ceramic crown by digital impression using intra oral scanner', 'armGroupLabels': ['Digital impression with intraoral scanner']}, {'name': 'impression analog', 'type': 'DEVICE', 'otherNames': ['implant placement', 'impression copying'], 'description': 'Immediate implant placement with customized healing abutment and after three months placement of all ceramic crowns by conventional impression', 'armGroupLabels': ['conventional impression technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11566', 'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'ola A ezzat, professsor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'faculty of dentistry-Ain shams university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}