NCT05360693

Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant

Evaluation of Horizontal and Vertical Labial Bone Dimensional Changes After Flapless Immediate Implant Placement With and Without Bone Grafting: A 1-year Cone-beam Computed Tomography Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

For the dimension of the peri-implant buccal gap, a controversy is present whether complete bone formation labial to the implant. Therefore, leaving the blood clot in the large socket around implants without augmentation is questionable to result in complete bone fill and would not affect the buccal contour collapse. The aim of this clinical trial was to evaluate the labial bone dimensional changes after immediate implant placement in the esthetic zone with \& without bone grafting inside the socket by using CBCT superimposition (Fusion) scans.

Conditions

• Immediate Implants
• Esthetic Zone
• Labial Bone Dimensional Changes
• Without Labial Bone Grafting
• With Labial Grafting
• Thin Labial Plate of Bone Pre-extraction

Interventions

Type	Name	Description
PROCEDURE	immediate implant placement without bone grafting	After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done \& patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.
PROCEDURE	immediate implant placement with socket bone grafting	After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done and patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). In order to ensure standardization and reproducibility of the CBCT cross sectional images used in this study, superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.

Timeline

• Start date: 2020-11-01
• Primary completion: 2022-04-01
• Completion: 2022-04-29
• First posted: 2022-05-04
• Last updated: 2022-09-08

Locations

2 sites across 1 country: Egypt