Alveolar Bone GraftingNCT07295041
GBR Versus Allogenic Bone Block
A study testing allogenic bone blocks and allogenic cancellous bone granules in people with Alveolar Bone Grafting and Implant Placement, run by Algirdas Puisys, DDS, PhD at 1 site in Lithuania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Grafting, Implant Placement
- What is being tested?
- allogenic bone blocks and allogenic cancellous bone granules
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteLithuania
- Study dates
- 1 May 2018to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Alveolar Bone Grafting, Implant Placement
- Being tested
- allogenic bone blocks, allogenic cancellous bone granules
- Keywords
- bone block, GBR, guided bone regeneration, allogenic graft, bone particulate, allogenic bone block, allogenic bone particulate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogenic bone blocksProcedure or surgery
An allogenic bone blocks were used for the primary bone augmentation procedure.
allogenic cancellous bone granulesProcedure or surgery
allogenic cancellous bone granules were used for the primary bone augmentation procedure.
| Study group | Role | What they receive |
|---|---|---|
| allogenic bone blocks | Active comparator | Patients in this group received allogenic bone blocks for the primary bone augmentation procedure. Receives: 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. Receives: Procedure: allogenic cancellous bone granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 6 months
Keratinized tissue height
keratinized tissue height measured with a periodontal probe at baseline and follow-up.
Measured: Baseline and 6 months
Vertical soft tissue thickness
the vertical soft tissue thickness measured with a periodontal probe at baseline and follow-up.
Measured: Baseline and 6 months
Clinically measured bone width
the bucco-oral bone width measured with a periodontal probe at baseline and follow-up.
Measured: Baseline and 6 months
Radiologically measured bone width
Bucco-oral bone width in the augmented region was measured on baseline and follow-up CBCTs.
Measured: 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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 May 2018
- Primary completion24 Jan 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone GraftingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Algirdas Puisys, DDS, PhD
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Algirdas Puisys, DDS, PhD, Vilniaus Implantologijos Centro (VIC) Klinika
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295041
- Sponsor's protocol ID
- BEC-LSMU(R)-51
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogenic Bone Blocks and Particulate Graft for Horizontal Bone Augmentation in the Posterior Mandible: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07295041
- Acronym / sponsor ID
- BEC-LSMU(R)-51
- Conditions
- Alveolar Bone Grafting, Implant Placement
- Keywords
- bone block, GBR, guided bone regeneration, allogenic graft, bone particulate, allogenic bone block, allogenic bone particulate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Algirdas Puisys, DDS, PhDResearch network
- Study start
- 1 May 2018 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allogenic bone blocks | Active comparator | Procedure: allogenic bone blocksPatients in this group received allogenic bone blocks for the primary bone augmentation procedure. |
| allogenic cancellous bone granules | Active comparator | Procedure: allogenic cancellous bone granulesPatients in this group received allogenic cancellous bone granules for the primary bone augmentation procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogenic bone blocksAn allogenic bone blocks were used for the primary bone augmentation procedure. | Procedure or surgery | allogenic bone blocks |
| allogenic cancellous bone granulesallogenic cancellous bone granules were used for the primary bone augmentation procedure. | Procedure or surgery | allogenic cancellous bone granules |
Primary outcome
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.
6 secondary outcomes
Need for further augmentation procedures at the time of implant placement
Time frame: 6 months
Keratinized tissue height
Time frame: Baseline and 6 months
Vertical soft tissue thickness
Time frame: Baseline and 6 months
Clinically measured bone width
Time frame: Baseline and 6 months
Radiologically measured bone width
Time frame: Baseline and 6 months
Changes in bone volume
Time frame: Baseline and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Alveolar Bone Grafting
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Alveolar Bone Loss, Tooth Loss / Rehabilitation
Not yet recruiting
Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
Not yet recruiting
Hyaluronic Acid Combined With Xenograft Versus Xenograft Alone in Immediate Implant Placement
Immediate Implant Placement in the Esthetic Zone, NON-RESTORABLE TOOTH IN ESTHETIC ZONE
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allogenic bone blocks and allogenic cancellous bone granules in people with Alveolar Bone Grafting and Implant Placement, run by Algirdas Puisys, DDS, PhD at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological composition (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.