GBR Versus Allogenic Bone Block

NCT07295041 | Completed

• 1 other identifier: BEC-LSMU(R)-51
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alveolar Bone Grafting; Implant Placement

Keywords

bone block, GBR; guided bone regeneration; allogenic graft; bone particulate; allogenic bone block; allogenic bone particulate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Need for further augmentation procedures at the time of implant placement

  6 months

• Keratinized tissue height

  Baseline and 6 months

• Vertical soft tissue thickness

  Baseline and 6 months

• Clinically measured bone width

  Baseline and 6 months

• Radiologically measured bone width

  Baseline and 6 months

Study Arms (2)

allogenic bone blocks

ACTIVE COMPARATOR

Patients in this group received allogenic bone blocks for the primary bone augmentation procedure.

Procedure: allogenic bone blocks

allogenic cancellous bone granules

ACTIVE COMPARATOR

Patients in this group received allogenic cancellous bone granules for the primary bone augmentation procedure.

Procedure: allogenic cancellous bone granules

Interventions

allogenic bone blocks PROCEDURE

An allogenic bone blocks were used for the primary bone augmentation procedure.

allogenic bone blocks

allogenic cancellous bone granules PROCEDURE

allogenic cancellous bone granules were used for the primary bone augmentation procedure.

allogenic cancellous bone granules

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Algirdas Puisys, DDS, PhD: lead

Study Sites (1)

VIC Klinika

Vilnius, Lithuania

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS, PhD

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 19, 2025
• Study Start: May 1, 2018
• Primary Completion: January 24, 2024
• Study Completion: January 1, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)