Immediate Implant Placement Utilizing Vestibular Flap Versus Single Flap Approach With Bone Graft
NCT ID: NCT06207565
Last Updated: 2025-04-18
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
34 participants
INTERVENTIONAL
2025-09-01
2026-08-01
Brief Summary
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Detailed Description
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Different flap designs available include vestibular incision, papilla sparing, envelope, triangular, and trapezoidal. Selection of the ideal flap design is case dependent, and is based on several factors such as, smile line, gingival biotype, width of the edentulous area, and the proposed treatment plan. It has also been reported that flapless implant placement is a predictable procedure with a high success rate and less patient discomfort, minimizing the overall procedure time, postoperative pain, and inflammation. However, flapless surgery has been regarded as a technique with limitations regarding bone augmentation.
Therefore, cases with labial bone defects during immediate implant placement require flap mobilization to achieve the needed coverage for ridge augmentation, despite of the proposed drawbacks to flap reflection, such as the increased postoperative sequelae, recovery time, and reduced blood supply after flap adaptation. A single flap approach, a modified form of the envelope flap, has been suggested as an alternative to allow for ridge augmentation in esthetic immediate implant cases with labial bone defects. Whereas the vestibular incision, one horizontal full-thickness incision in the vestibule is considered a minimally invasive aesthetic ridge augmentation technique away from the gingival margin and sulcus, intending to maintain the volume and contour of the supra crestal soft tissue.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vestibular Flap Group
Vestibular Flap with immediate implant placement, bone graft and customized healing abutment.
Vestibular Flap Group
Achieving the vestibular flap, a 1-cm long horizontal vestibular access incision using a 15c blade 3-4mm apical to the mucogingival junction of the hopeless tooth, exposing the alveolar bone. Flap dissection in a coronal direction to detach the periosteum is completed, forming a sub-periosteal tunnel.
Single Flap Approach group
Single Flap approach with immediate implant placement, bone graft and customized healing abutment.
Single Flap Approach group
A modified envelope flap originally reported as an access flap for single implant insertion in areas of esthetic relevance will be performed. A sulcular incision on the labial aspect extending at least one tooth mesial and distal to the implant site (permitting enough accessibility for bone augmentation) is done. The flap is reflected by performing a split-thickness flap elevation starting from the interproximal incisions, leaving the anatomical papillae in situ. While the full-thickness flap elevation is performed on the labial aspect of the included surgical area, starting at the sulcus, and reaching at least 3 mm apical to the bone crest.
Interventions
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Vestibular Flap Group
Achieving the vestibular flap, a 1-cm long horizontal vestibular access incision using a 15c blade 3-4mm apical to the mucogingival junction of the hopeless tooth, exposing the alveolar bone. Flap dissection in a coronal direction to detach the periosteum is completed, forming a sub-periosteal tunnel.
Single Flap Approach group
A modified envelope flap originally reported as an access flap for single implant insertion in areas of esthetic relevance will be performed. A sulcular incision on the labial aspect extending at least one tooth mesial and distal to the implant site (permitting enough accessibility for bone augmentation) is done. The flap is reflected by performing a split-thickness flap elevation starting from the interproximal incisions, leaving the anatomical papillae in situ. While the full-thickness flap elevation is performed on the labial aspect of the included surgical area, starting at the sulcus, and reaching at least 3 mm apical to the bone crest.
Eligibility Criteria
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Inclusion Criteria
* Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
* Buccal bone thickness less than 1mm assessed in CBCT with good apical bone for implant primary stability.
* Good oral hygiene
* Patient accepts to provide an informed consent.
Exclusion Criteria
* Pregnant and lactating females.
* Medically compromised patients.
* Patients with active infection related at the site of implant/bone graft placement.
* Patients with untreated active periodontal diseases.
* Patients with parafunctional habits.
20 Years
ALL
Yes
Sponsors
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Misr International University
OTHER
Responsible Party
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Ahmed Abo El Futtouh
Clinical director of implant speciality program
Central Contacts
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Other Identifiers
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IDCE.N6
Identifier Type: -
Identifier Source: org_study_id
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