NCT06312384

The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation

The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patients With Labial Alveolar Ridge Defect and Simultaneous Implantation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluate the impact of using 3D surgical template with guided bone regeneration technique on the contour of bone augmentation in patients with horizontal labial ridge defect and simultaneous implantation.

Detailed description

Because adequate bone wrapping around the implant is critical for long-term effectiveness of dental implant treatment, bone augmentation in the bone defect area is required to repair the width and height of the alveolar bone, as bone resorption occurs following tooth extraction. Many bone augmentation techniques, such as onlay block grafting, bone splitting, distraction osteogenesis, and guided bone regeneration, are currently accessible in clinics (GBR). Surgical options vary depending on the severity of the bone deformity. GBR is a bone augmentation technique that has more evidence-based medicine support and therapeutic applications, as well as the benefits of less surgical stress and low technical sensitivity. Establishing aesthetics and guaranteeing long-term success in implant therapy can be challenging. Long-term stable implant success has been linked to the presence of more than 2mm labial graft thickness, and appropriate labial graft thickness is essential to preserve crestal bone level and prevent marginal soft tissue recession. According to a meta-analysis of 15 randomized-controlled trials, the estimated mean (SD) bone resorption for GBR in lateral ridge augmentation throughout the 6-month healing period was 1.22-0.28 mm. As a result, a 3.5 mm thickness of labial graft at all levels may be necessary following wound closure to compensate for potential graft loss. Traditional bone augmentation is often dependent on the operator's skill, therefore virtually digital guided bone regeneration (GBR) process offers the digital options for precise and controllable bone augmentation in the field of oral implantology . Specific aim: to compare the contour of bone augmentation (peri-implant bone volume) between various (GBR) procedures in patients with lateral alveolar ridge defect and simultaneous implantation. Hypothesis: patients with lateral alveolar ridge defect and simultaneous implantation subjected to a 3D printing surgical template with GBR are associated with radiographic evidence of more labial graft thickness and volume stability after six months post-surgical than patients with conventional GBR protocol.

Conditions

• Bone Deformity

Interventions

Type	Name	Description
PROCEDURE	3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation	a two-piece tooth-supported surgical template will fabricated through 3D printing technology before surgery base on the digital simulation of bone graft contour.Sticky bone will placed into the defect under the guidance of the template to form customized sticky bone and will be covered with collagen membrane.
PROCEDURE	conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation	The defected site will be grafted with sticky bone (particulate bone substitute mixed with injectable platelet-rich fibrin (i-PRF)) and will be covered with collagen membrane.

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2024-03-15
• Last updated: 2024-03-15

Locations

1 site across 1 country: Egypt