GBR Versus Allogenic Bone Block

Allogenic Bone Blocks and Particulate Graft for Horizontal Bone Augmentation in the Posterior Mandible: a Randomized Controlled Trial

This study aimed to compare two different methods used to augment bone in the posterior lower jaw prior to implant placement in patients with insufficient bone width. Eligible patients were included in the study and received a horizontal bone augmentation with one of two methods, which differed in the materials used for the bone augmentation. The group allocation was randomised. After 6 months of healing following parameters were assessed: histological evaluation, survival of the bone graft, the need for further bone augmentation at the time of implant placement, changes in soft tissue characteristics, radiologically and clinically assessed changes in bone width.

Study Overview

• Status: Completed
• Conditions: Alveolar Bone Grafting; Implant Placement
• Intervention / Treatment: Procedure: allogenic bone blocks; Procedure: allogenic cancellous bone granules

Detailed Description

Objective: The objective of this study is to compare the histological, clinical, and radiographic outcomes of particulate bone substitutes versus allogenic bone block grafts for primary bone augmentation in the posterior mandible.

Materials and Methods: This randomised controlled clinical trial included adult patients in need for a staged bone augmentation prior to implant placement in the posterior mandible. Patients were randomly assigned to one of two treatments groups. Patients allocated in the BBL group received allogenic bone blocks, whereas patients in the GBR group received allogenic bone granules for the primary bone augmentation. In both groups grafting materials were covered with a resorbable collagen membrane, which was fixated with non-resorbable fixation pins. The primary outcome of this study was defined as the composition of the histological samples at least 6 months after the primary bone augmentation. Secondary outcomes included graft survival rates, the need for further augementation procedures at time of implant placement, soft tissue measurements and radiographically and clinically analyzed changes in bone width and radiographically analyzed changes in bone volume. These outcomes were measured at baseline (prior to bone augmentation surgery) and at the follow-up (at least 6 months after bone augmentation).

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania
    • VIC Klinika

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged ≥18 years
• Insufficient bone width in posterior mandible requiring staged bone augmentation prior to implant placement
• Minimum of 1 mm bone width available
• Willing to provide signed informed consent

Exclusion Criteria:

• Pregnant or lactating
• Known or suspected incompliance
• Patients smoking more than 10 cigarettes per day
• Systemic diseases or medications affecting bone metabolism (such as osteoporosis, intake of bisphosphonates)
• Active periodontal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: allogenic bone blocks; Patients in this group received allogenic bone blocks for the primary bone augmentation procedure.	Procedure: allogenic bone blocks; An allogenic bone blocks were used for the primary bone augmentation procedure.
Active Comparator: allogenic cancellous bone granules; Patients in this group received allogenic cancellous bone granules for the primary bone augmentation procedure.	Procedure: allogenic cancellous bone granules; allogenic cancellous bone granules were used for the primary bone augmentation procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological composition	Histological samples were obtained at the time of reentry for implant placement at least 6 months after the primary bone augmentation procedure. Sample analysis included the measurement of the total sample area, the area of identified bone, biomaterial and soft tissue per sample. Furthermore, the percentage of bone, biomaterial and soft tissue per sample was calculated.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for further augmentation procedures at the time of implant placement	The need for further soft and hard tissue augmentation procedures at the time of implant placement was evaluated at the time of implant placement.	6 months
Keratinized tissue height	keratinized tissue height measured with a periodontal probe at baseline and follow-up.	Baseline and 6 months
Vertical soft tissue thickness	the vertical soft tissue thickness measured with a periodontal probe at baseline and follow-up.	Baseline and 6 months
Clinically measured bone width	the bucco-oral bone width measured with a periodontal probe at baseline and follow-up.	Baseline and 6 months
Radiologically measured bone width	Bucco-oral bone width in the augmented region was measured on baseline and follow-up CBCTs.	Baseline and 6 months
Changes in bone volume	CBCT images prior to bone augmentation and after the healing period were superimposed. The changes in bone volume in the augmented area were measured.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: Algirdas Puisys, DDS, PhD

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): January 24, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: guided bone regeneration; bone block, GBR; allogenic graft; bone particulate; allogenic bone block; allogenic bone particulate
• Other Study ID Numbers: BEC-LSMU(R)-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No