Immediate Implant Placement Utilizing Vestibular Flap Versus Single Flap Approach With Bone Graft
- Conditions
- Immediate Implant Placement
- Interventions
- Procedure: Vestibular Flap GroupProcedure: Single Flap Approach group
- Registration Number
- NCT06207565
- Lead Sponsor
- Misr International University
- Brief Summary
Due to the evolution of esthetic implant dentistry and tissue regeneration (hard and soft tissue), flap design plays a crucial role in the maintenance and regeneration of the marginal soft tissue and interdental papillae around dental implants. The present study aims to compare soft and hard tissue changes following immediate implant placement with ridge augmentation using the vestibular flap versus single flap approach.
- Detailed Description
Achieving and maintaining optimal esthetics around maxillary anterior single implants is a demanding task. Despite the high success rates achieved with osseointegrated implants, inevitable loss of soft and hard tissue following tooth extraction often results in compromised vertical and horizontal dimensions of the peri-implant soft tissue in terms of esthetics. Various surgical techniques have been advocated to overcome the expected alveolar ridge dimensional changes in immediate implant placement, including the use of connective tissue grafts, bone grafts, flapless implant placement protocol and the different flap designs .
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 34
- Patients who have one non-restorable maxillary anterior (Canine to Canine region) with sound adjacent teeth.
- 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.
- Smokers
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vestibular Flap Group Vestibular Flap Group Vestibular Flap with immediate implant placement, bone graft and customized healing abutment. Single Flap Approach group Single Flap Approach group Single Flap approach with immediate implant placement, bone graft and customized healing abutment.
- Primary Outcome Measures
Name Time Method Volumetric analysis of labial contour 12 months To evaluate tissue volume changes, Intra oral scans of the esthetic zone will be obtained. Changes in the soft tissue profile will be calculated as the difference between the digitized surface outline of the different profiles at the given time of maturation of the site. All the images recorded by the intra-oral scanner will be transmitted to a 3D viewer software (Exocad Gmbh) to assess and compare the linear and volumetric changes in the labial soft tissue contour in comparison to the original, at 2, 4 and 6 mm from the pre-operative gingival margin. All the scans will be superimposed to the pre-operative scan using 3-point alignment method that ensure standardization of the images.
- Secondary Outcome Measures
Name Time Method Labio-palatal bone width 12 months Two CBCT scans will be attained, primary (preoperative) scan (T0) and a secondary (Postoperative) scan 12 months after. In order to ensure standardization and reproducibility of the CBCT cross sectional images that will be used in this study, superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software will be done (Koerich et al., 2016). This 3D superimposition technique allows for sub-voxel accuracy and highly strong registration. Both files will be loaded in the Fusion module at the same time, first manual registration will be done by approximation of the secondary scan to the primary one in axial, sagittal and coronal cuts, then automatic registration by the software. The labiopalatal width will be measured at 2 points; 2 mm apical to the crest of the palatal bone and 5mm apical to the 1st line
Mid facial recession 12 months Will be measured in mm from the intraoral scans at T1, T2, T3 and compared to that of T0. The reference point will be the most apical part of the midfacial gingival level.
Interdental papillae height 12 months Will be measured in mm from the intraoral scans at T1, T2, T3 and compared to that of T0. Mesial and distal papillae will be evaluated individually.