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Completed

NCT Number: NCT07295041

GBR Versus Allogenic Bone Block

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VIC Klinika

Vilnius, Lithuania

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

allogenic bone blocks

Procedure

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

allogenic cancellous bone granules

Procedure

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

Primary outcomes

  1. Histological composition

    Time frame: 6 months

    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.

Secondary outcomes

  1. Need for further augmentation procedures at the time of implant placement

    Time frame: 6 months

    The need for further soft and hard tissue augmentation procedures at the time of implant placement was evaluated at the time of implant placement.

  2. Keratinized tissue height

    Time frame: Baseline and 6 months

    keratinized tissue height measured with a periodontal probe at baseline and follow-up.

  3. Vertical soft tissue thickness

    Time frame: Baseline and 6 months

    the vertical soft tissue thickness measured with a periodontal probe at baseline and follow-up.

  4. Clinically measured bone width

    Time frame: Baseline and 6 months

    the bucco-oral bone width measured with a periodontal probe at baseline and follow-up.

  5. Radiologically measured bone width

    Time frame: Baseline and 6 months

    Bucco-oral bone width in the augmented region was measured on baseline and follow-up CBCTs.

  6. Changes in bone volume

    Time frame: Baseline and 6 months

    CBCT images prior to bone augmentation and after the healing period were superimposed. The changes in bone volume in the augmented area were measured.

Sponsors and collaborators

Lead sponsor

Algirdas Puisys, DDS, PhD

Network

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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