Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT07054658
Status:
COMPLETED
Last Update Posted:
2025-07-22
First Post:
2025-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Allogenic Bone Ring Graft With Simultaneous Implant Placement for Vertical Ridge Augmentation
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Evaluation of Allogenic Bone Ring Graft With Simultaneous Implant Placement for Vertical Ridge Augmentation
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aimed to evaluate the effectiveness of vertical ridge augmentation using customized allogenic bone ring grafts with simultaneous dental implant placement in the posterior mandible. The procedure is designed to address vertical bone deficiencies without the need for autogenous bone harvesting, thereby reducing patient morbidity and surgical complexity. The study assessed clinical outcomes including bone gain, implant stability, and over a 6-month period and inflammation, infection, pain and neurosensory changes where assessed for 4 weeks.
Detailed Description:
This study investigated the clinical outcomes of vertical ridge augmentation using allogenic bone rings in combination with simultaneous implant placement for the treatment of posterior mandibular bone defects. Traditional ridge augmentation techniques often require two-stage surgeries and autogenous bone harvesting, which may increase patient morbidity and prolong healing. In contrast, the allogenic bone ring technique provides a one-stage approach by allowing vertical augmentation and implant placement to be performed simultaneously.
The study was designed as a prospective, single-arm clinical trial. Eligible patients aged 18 years or older, presenting with vertical bone deficiencies in the posterior mandible, were recruited from the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. The primary outcome was vertical bone gain measured radiographically at 6 months postoperatively. Secondary outcomes included implant stability (measured by IST), soft tissue healing, and postoperative complications. Patients were followed clinically and radiographically to evaluate the success of the grafting procedure and implant integration.
The study was designed as a prospective, single-arm clinical trial. Eligible patients aged 18 years or older, presenting with vertical bone deficiencies in the posterior mandible, were recruited from the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. The primary outcome was vertical bone gain measured radiographically at 6 months postoperatively. Secondary outcomes included implant stability (measured by IST), soft tissue healing, and postoperative complications. Patients were followed clinically and radiographically to evaluate the success of the grafting procedure and implant integration.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: