None listed
Conditions
Brief summary
This study aims to evaluate the efficiency of dental implant placement with immediate loading using stackable surgical guides. It will focus on key outcomes such as implant stability, osseointegration, functional success, and patient satisfaction over a 12-month follow-up period. Digital planning, including CBCT and facial scans, will be utilized to ensure precise implant placement. The findings will provide insights into the effectiveness of stackable guides and immediate loading protocols in improving clinical outcomes. We hypothesize that stackable surgical guides will enhance implant placement accuracy, stability, improve osseointegration, and increase patient satisfaction compared to conventional single-layer guides in immediate loading.
Interventions
Intervention name: Dental implant placement with immediate loading using stackable surgical guide. Placing four dental implants according to the All-on-Four concept on edentulous patients or patients with teeth indicated for extraction using a stackable surgical guide. This involves immediate placement of a full-arch restoration fixed onto four implants in the mandible on the same day. The process includes the following details: 1. Preoperative Data Collection (Duration: Approximately 75 minutes) 1.1 Patient consultation and clinical examination. 1.2 Obtain digital maxillary and mandibular primary impressions and accurate bite registration. 1.3 Obtain skull cone beam computed tomography (CBCT) with the patient wearing the bite registration. 1.4 Facial scan: Perform a 3D facial scan using photogrammetry. This scan captures the patient's facial anatomy, including soft tissue contours, essential for ensuring optimal aesthetic outcomes. 2. Digital Implant Planning 2.1 Merging Data Sets: Merge the CBCT scan, intraoral scan, and facial scan in specialized implant planning software (r2gate). This integrated model provides a 3D representation of the patient’s facial soft tissue, dentition, and underlying bone structures. 2.2 Implant Positioning: Determine the ideal implant positions (angulation, depth, and distance between implants) to ensure proper support for the immediate loading prosthesis. 3. Design of Stackable Surgical Guide 3.1 Guide Design: Design a stackable surgical guide in the planning software. The guide includes multiple stackable layers for different surgical steps: Base Guide: Fits onto the patient's arch or edentulous ridge, providing stability, and may be used as a guide for bone reduction if needed. Base Carrier: Seated on the remaining teeth or bone, providing stability and acting as a support platform for the base guide. Implant Placement Guide: Guides the surgical drill for precise osteotomy at the planned implant sites, ensuring correct positioning and angulation during implant insertion. Abutment Guide: After implant placement, this guide helps position the abutments precisely on the implant heads to ensure proper orientation for the final restoration. Provisional Restoration Guide: Ensures accurate placement of the provisional restoration, accounting for abutment position, occlusion, and esthetics. 3.2 3D Printing of the Surgical Guide: Export the guide design as an STL file and send it to a 3D printer. The guide is printed using biocompatible materials that are sterilizable for surgical use. 4. Surgical Procedure (Duration: Approximately 90 minutes) The intervention will be provided by Oral and maxillofacial surgery PhD resident with 5 years experience in dental surgery, 4.1 Pre-Surgical Preparations: Administer local anesthesia and prepare the surgical site. Verify the fit of the base surgical guide in the patient’s mouth to ensure stability and accurate positioning. 4.2 Guide Placement: Secure the base layer of the stackable guide onto the patient's arch or edentulous ridge. The guide should fit passively without any pressure points. Sequentially place the other layers of the guide as needed for each surgical step. 4.3 Osteotomy (Drilling): Using the drilling guide layer, perform osteotomies at the predetermined implant sites. The guide ensures precise angulation and depth control during drilling. 4.4 Implant Placement: Once the osteotomies are completed, switch to the implant placement guide layer. Insert the implants through the guide, ensuring precise placement in terms of depth and angulation. Measure and record the insertion torque to assess primary stability, which is critical for immediate loading. 5. Immediate Loading and Prosthesis Placement 5.1 Immediate Loading Prosthesis: After implant placement, place the prefabricated immediate loading prosthesis. This provisional prosthesis is digitally designed and created before surgery based on the virtual implant plan. Attach the prosthesis to the implants with a temporary fixation method, depending on stability. 5.2 Occlusal Adjustments: Perform occlusal adjustments to ensure proper bite alignment and distribute functional forces evenly across the implants. Verify the esthetic outcome by evaluating the prosthesis in relation to the patient’s facial scan (e.g., lip support, smile line). 6. Postoperative Care Postoperative Medications Provided: Antibiotics (e.g., amoxicillin or clindamycin, based on the patient's medical profile), pain relievers (e.g., ibuprofen or paracetamol), and an antimicrobial mouth rinse (e.g., chlorhexidine) are provided to reduce infection risk and manage discomfort. Care Instructions Delivery: Patients receive postoperative care instructions in a printed handout detailing dietary guidelines, oral hygiene protocols, and tips for minimizing discomfort. Adherence Monitoring: Patient adherence to postoperative care protocols will be monitored through weekly follow-up visits in the first month and then one visit each month. Adherence questionnaire also will be used.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Edentulous patients or with teeth indicated for extraction. 2. Have adequate, good quality bone in the mandible 3. sufficient width of attached gingiva around implant (2 mm minimum) 4. All implants can be seated with a torque > 35Ncm and have initial primary stability and ISQ 65 and above.
Exclusion criteria
1. parafunctional habits 2. systemic diseases affect the implant osteointegration. 3. local contraindication for implant. 4. History of previous chemotherapy or radiological therapy. 5. Treated with drugs that affect bone modeling