Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-01-04 @ 1:48 PM
Study NCT ID:
NCT03334994
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2017-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using CTG Around Immediate Dental Implants vs Immediate Dental Implants Alone in the Esthetic Zone.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Blinded participants: patient will be ensured by masking the instruments during the surgery. The patient will be informed of the steps of the surgery (as mentioned in the consent form) without getting into details. Blinding to the clinical, radiographic assessors is done by not involving them in sequence generation or allocation concealment or surgery performing.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients was randomly classified into two groups:\n\nGroup A: Patient will be treated with immediate implant alone. Group B: Patients will be treated with connective tissue graft combined with immediate implant.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2017-11-03', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facial gingival level', 'timeFrame': 'Up to 6 months', 'description': 'FGL was evaluated by measuring the distance between the level of soft tissues and the lower border of the customized template that was used as a reference line at three readings mesially, mid-facially and distally.'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'Up to 12 days', 'description': 'Visual analog scale was recorded every day for 12 days follow-up and the patient marks on the line the point they feel that it represents their response'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Up to 6 month', 'description': "Post-Surgical Patient Satisfaction Questionnaire (PSPSQ). The patient questionnaire evaluates patients' perception and subjective admiration of the final result of the treatment"}, {'measure': 'Tissue biotype', 'timeFrame': 'Up to 6 months', 'description': 'Thickness of the peri-implant mucosa around the implant'}, {'measure': 'Pink esthetic score', 'timeFrame': 'Up to 6 months', 'description': 'seven different variables: mesial papilla, distal papilla, facial soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture at the facial aspect of the implant site'}, {'measure': 'Width of keratinized mucosa', 'timeFrame': 'Up to 6 months', 'description': 'distance from the mucogingival junction (MGJ) to the gingival margin'}, {'measure': 'Bleeding on probing', 'timeFrame': 'Up to 6 months', 'description': 'Bleeding was provoked by sweeping the peri-implant mucosal sulcus using a periodontal probe.'}, {'measure': 'Probing depth', 'timeFrame': 'Up to 6 months', 'description': 'distance from the peri- implant mucosal margin to the bottom of the peri-implant sulcus'}, {'measure': 'Probing attachment level', 'timeFrame': 'Up to 6 months', 'description': 'distance from the base of the peri-implant sulcus to the implant shoulder using periodontal probe at four sites'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate dental implant, Connective tissue graft, Esthetic zone.'], 'conditions': ['Immediate Dental Implants Connective Tissue Graft Esthetic Zone']}, 'descriptionModule': {'briefSummary': 'Aim of current study to evaluate connective tissue graft combined with immediate implant placement as an innovative option for less facial gingival tissue recession, less pocket depth and less clinical attachment loss versus immediate implant alone.', 'detailedDescription': 'P: Adult patients with single or multiple non-restorable teeth in esthetic zone I: Immediate implant + Connective tissue graft. C: Immediate implant alone. O: Primary Outcome: Facial gingival level Secondary Outcome: Patient satisfaction, probing depth, probing attachment loss, tissue biotype, keratinized mucosal width and bleeding on probing.\n\nP.M will select patients from the outpatient clinic of the Oral Medicine and Periodontology Department - Cairo University. Screening of patients will continue until the target population is achieved. Identifying and recruiting potential subjects is achieved through patient database.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18-55\n2. Patients with single or multiple non-restorable teeth in maxillary anterior or premolar area.\n3. Patients with adequate bone volume for the dental implant procedure.\n4. Patients who are compliant to oral hygiene measures.\n5. Patient consent approval and signing.\n\nExclusion Criteria:\n\n1. Heavy smokers.\n2. Systemic disease that contraindicates implant placement or surgical procedures.\n3. No or poor patient's compliance.\n4. Psychological problems.\n5. Pathology at the site of intervention.\n6. Pregnancy females."}, 'identificationModule': {'nctId': 'NCT03334994', 'briefTitle': 'Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using CTG Around Immediate Dental Implants vs Immediate Dental Implants Alone in the Esthetic Zone.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Facial Gingival Level Evaluation Following Soft Tissue Augmentation Using Connective Tissue Graft Around Immediate Dental Implants Versus Immediate Dental Implants Alone in the Esthetic Zone. Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '302017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group: immediate implant alone', 'description': 'Patient will be treated with immediate implant alone.', 'interventionNames': ['Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(Group A) immediate implant alone', 'description': 'Patient will be treated with immediate implant alone.', 'interventionNames': ['Procedure: Intervention group:(Group B) connective tissue graft combined with immediate implant.']}], 'interventions': [{'name': 'Intervention group:(Group B) connective tissue graft combined with immediate implant.', 'type': 'PROCEDURE', 'description': 'Patients will be treated with connective tissue graft combined with immediate implant.', 'armGroupLabels': ['(Group A) immediate implant alone', 'Control group: immediate implant alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Cairo University, Faculty of Dentistry.', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Parryhan Mohamed Abdelsamie', 'investigatorAffiliation': 'Cairo University'}}}}