Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-04-08 @ 6:46 PM
Study NCT ID:
NCT07333534
Status:
RECRUITING
Last Update Posted:
2026-03-13
First Post:
2025-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hard Tissue Augmentation With or Without Connective Tissue Graft in Immediate Esthetic Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2025-12-15', 'studyFirstSubmitQcDate': '2025-12-29', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pink Esthetic Score (PES)', 'timeFrame': 'Pink esthetic score (PES) will be assessed at 6 months postoperatively.', 'description': 'Seven variables to be scored: mesial papilla, distal papilla, curvature of the facial mucosa, level of the facial mucosa, alveolar process, soft tissue color, and texture of facial gingiva at the implant site. A score of 0, 1, or 2 will be given to each parameter to obtain a final score of 14.'}], 'secondaryOutcomes': [{'measure': 'Hard tissue assessment (facial bone thickness)', 'timeFrame': '6 months postoperatively', 'description': 'Using Cone-Beam Computed Tomography (CBCT) to assess the thickness of the facial (labial/buccal) plate of bone at two points: the implant platform and a point 5mm apical to the implant platform.'}, {'measure': 'Patient satisfaction questionnaire', 'timeFrame': '6 months postoperatively', 'description': 'Assessment of patient satisfaction will be performed at 6 months postoperatively with a self-administered patient questionnaire regarding overall satisfaction and satisfaction of color and shape of the mucosa using a visual analogue scale (VAS, left = very dissatisfied \\[0\\], right = very satisfied \\[10\\].'}, {'measure': 'Implant survival rate', 'timeFrame': '6 months postoperatively', 'description': 'Implant survival rate at 6 months (defined by absence of mobility, infection, pain, and peri-implant bone loss).'}, {'measure': 'Rate of complications', 'timeFrame': 'From the intervention to 6 month postoperatively', 'description': 'complications such as infection, graft rejection and peri-implantitis will be assessed from the intervention up to 6 months postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immediate implant', 'maxillary esthetic zone', 'CTG', 'jumping gap', 'bone augmentation'], 'conditions': ['Dental Implant']}, 'descriptionModule': {'briefSummary': 'This randomized controlled study is aimed to evaluate the esthetic, clinical, and radiographic outcomes following the placement of immediate single-tooth implant with hard and soft tissue augmentation.\n\nSubjects will randomly assigned to one of two groups:\n\n* Group A (control group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation only.\n* Group B (study group) receiving an immediate single-tooth implant in the esthetic zone with bone augmentation and connective tissue graft (CTG).\n\nThe main questions it aims to answer is:\n\nIs there is a significant difference in the esthetic outcome between bone augmentation alone and bone augmentation combined with connective tissue graft after immediate dental implant in the esthetic zone?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a non-restorable tooth or a remaining root without signs of acute infection in the maxillary esthetic zone.\n* The failing tooth is an incisor, canine or first bicuspid in the maxilla bounded by natural sound teeth.\n* Sufficient bone (\\>4 mm) apically and palatally to allow for proper implant positioning with sufficient primary stability (≥35 N cm).\n* Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.\n\nExclusion Criteria:\n\n* Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes).\n* Teeth with current acute periapical infection.\n* Dehiscence of the labial (facial) bone plate after extraction.\n* Signs of uncontrolled periodontal disease.\n* Heavy smokers and vulnerable groups (pregnant females and decision-impaired individuals).\n* History of head and neck radiation therapy.'}, 'identificationModule': {'nctId': 'NCT07333534', 'briefTitle': 'Hard Tissue Augmentation With or Without Connective Tissue Graft in Immediate Esthetic Implants', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': 'Effectiveness of Hard Tissue Augmentation With or Without Connective Tissue Graft Following Immediate Dental Implants in the Esthetic Zone: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '973124'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hard tissue augmentation with connective tissue graft', 'description': 'Hard tissue augmentation (bone grafting) with additional connective tissue graft (CTG) performed at the same time following immediate dental implant in the esthetic zone', 'interventionNames': ['Procedure: Immediate dental implant in the esthetic zone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hard tissue augmentation', 'description': 'Hard tissue augmentation (bone grafting) following immediate dental implant in the esthetic zone.', 'interventionNames': ['Procedure: Immediate dental implant in the esthetic zone']}], 'interventions': [{'name': 'Immediate dental implant in the esthetic zone', 'type': 'PROCEDURE', 'description': 'Placement of immediate dental implant after tooth extraction in the maxillary esthetic zone.', 'armGroupLabels': ['Hard tissue augmentation', 'Hard tissue augmentation with connective tissue graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10047', 'city': 'Baghdad', 'state': 'Rusafa', 'status': 'RECRUITING', 'country': 'Iraq', 'contacts': [{'name': 'Hassanien Al-Jumaily', 'role': 'CONTACT', 'email': 'hassanienaljumaily@codental.uobaghdad.edu.iq', 'phone': '+9647708896181'}], 'facility': 'University of Baghdad/ College of Dentistry/ Department of Oral and Maxillofacial surgery/ Implant Unit', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}], 'centralContacts': [{'name': 'Khalid Khalid, Bachelor of Dental Surgery', 'role': 'CONTACT', 'email': 'khaled.waleed2408m@codental.uobaghdad.edu.iq', 'phone': '+9647716641706'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Khalid Walid Khalid', 'investigatorAffiliation': 'University of Baghdad'}}}}