Clinical trial NCT06312384: The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation
Official title: The Influence of 3D Surgical Template on the Contour of Bone Augmentation, in Patients With Labial Alveolar Ridge Defect and Simultaneous Implantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Bone Deformity
Keywords: 3D surgical template, guided bone regeneration , the contour of bone augmentation ,horizontal labial ridge defect and simultaneous implantation.
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 \[Control group\]:

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 will be applied \[conventional GTR\].

Group 2 \[Study group\]:

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 will be applied, in this group 3D surgical template will be applied.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Healthy patients between the ages of 18 and 65 with edentulous ridge and seek for implant replacement.
2. In the anterior region, there is a labial bone defect.
3. Patients need the surgery in the first place to compensate for bone loss around implant.

Exclusion Criteria:

1. Systemic disorders that are out of control.
2. Heavy smokers (those who smoke more than 20 per day).
3. Women who are pregnant or nursing.
4. Thin gingival bio-type.

Primary outcomes:
measure: Change in Radiographic assessment for all patients underwent Cone beam computed tomography (CBCT) scans
timeFrame: baseline, immediately after and 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry-Mansoura University
Study officials:
References:
citation: Wang M, Zhang X, Li Y, Mo A. The Influence of Different Guided Bone Regeneration Procedures on the Contour of Bone Graft after Wound Closure: A Retrospective Cohort Study. Materials (Basel). 2021 Jan 27;14(3):583. doi: 10.3390/ma14030583.