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

NCT06312384 | Unknown Phase 3

• 1 other identifier: A04080622
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Deformity

Keywords

3D surgical template, guided bone regeneration , the contour of bone augmentation ,horizontal labial ridge defect and simultaneous implantation.

Outcome Measures

Primary Outcomes (1)

• Change in Radiographic assessment for all patients underwent Cone beam computed tomography (CBCT) scans

  The postoperative CBCT DICOM images were converted to STL files and overlaid over the preoperative CBCT.The thickness of the labial bone graft was measured from the labial outline of the bone graft to the implant as a result of the procedure. (T0-T5) Perpendicular to the simulated implant in the bucco-oral cross-sectional picture. The distance (width in millimeter) between the implant and the labial contour of the graft, which indicated the thickness of the labial bone graft, was measured at the implant shoulder (T0), as well as at 1, 2, 3, 4, and 5 mm apical to the implant shoulder (T1-T5). For each site, the standard deviation of T0, T1, and T2 (SDC) was calculated, which represents the uniformity of the graft contour in the coronal area.

  baseline, immediately after and 6 months after surgery

Study Arms (2)

study

ACTIVE COMPARATOR

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 which consist of a two-piece tooth-supported surgical template will fabricated through 3D printing technology before surgery base on the digital simulation of bone graft contour.

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

control

ACTIVE COMPARATOR

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 \[conventional guided tissue regeneration\].

Procedure: conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation

Interventions

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

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.

study

conventional guided bone regeneration,in Patient With Labial Alveolar Ridge Defect and Simultaneous Implantation PROCEDURE

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.

control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry-Mansoura University

Al Mansurah, 35516, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33513735 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: each patient will be couded and only the princeiple investigator is the only person how know the type of intervantion
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 15, 2024
• Study Start: July 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)