Evaluation of Allogenic Bone Ring Graft With Simultaneous Implant Placement for Vertical Ridge Augmentation

Not Applicable

Completed

• Conditions: Posterior Mandible With Deficient Ridge Height

• Registration Number: NCT07054658
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2024-05-23
• Primary Completion: 2025-01-31
• Study Completion: 2025-02-27
• Study First Submitted: 2025-06-27
• Study First Submitted QC: 2025-06-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Participants with vertical alveolar ridge atrophy in the posterior mandible who are motivated, cooperative, and have good oral hygiene.
• Minimum of 7 mm remaining bone height from the crest of the alveolar ridge to the inferior alveolar canal.
• Patients with adequate remaining interarch space

Exclusion Criteria

• Prior local radiation therapy.
• Soft and hard tissue pathology at the operation site.
• Systemic diseases that might affect bone healing and osseointegration (e.g., uncontrolled diabetes)..
• smokers who consume 20 or more cigarettes per day.
• patients on anti-resorptive drugs (eg: bisphosphonates and denosumab).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Vertical Bone Gain in mm	6 months postoperatively	The vertical bone gain was measured radiographically using CBCT imaging to evaluate the effectiveness of the allogenic bone ring graft in augmenting vertical bone height in the posterior mandible

Trial Locations

Locations (1)

Faculty of Dentistry, Tanta University; 🇪🇬 Tanta, Gharbia, Egypt