Bone AtrophyNCT06434441
Bone Augmentation Using Calvarial Versus Iliac Crest Bone Blocks.
A study testing Autogenous bone augmentation in people with Bone Atrophy, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Bone Atrophy
- What is being tested?
- Autogenous bone augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with the clinical and radiographic interpretation of horizontal maxillary ridge deficiency of less than 5 mm
Who cannot join
- Any previous maxillary reconstructive or dental implant treatment.
- Any local pathologic lesion or systemic disease that would affect the typical pattern of bone healing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Amr Gibaly
Cairo, 62764
Amr Gibaly, 01113336634, amrgibaly@dent.bsu.edu.eg
About this study
Official title: Radiographic Assessment of Horizontal Bone Augmentation of Full Atrophic Maxillary Alveolar Ridges Using Calvarial Versus Iliac Crest Bone Blocks:
This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones
Read the detailed description
Although the calvarial bones represent a nearby donor site for maxillary augmentation of matching bone origin, the excessive volume of bone needed to reconstruct a severely deficient arch, the limited cancellous bone volume, and the arciform pattern of the skull cap that yield the curvatures of the harvested cortical blocks incompatible with the topography of the maxillary arch, all represent limitations for the calvarial graft.
The anterior iliac crest is frequently used for free bone grafting by being subcutaneous and generous to afford ample bone blocks of favorable curvatures. However, the minute cortical overlay and its endochondral origin contribute to excessive graft resorption. Pikos et al. demonstrated that a reasonable amount of graft resorption could occur with atraumatic surgical intervention and intimate graft fixation.
This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones.
- Conditions
- Bone Atrophy
- Being tested
- Autogenous bone augmentation
- Keywords
- Bone graft, Iliac crest blocks, Calverial bone blocks, Horizontal bone gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous bone augmentationProcedure or surgery
Maxillary alveolar bone reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Study group: | Active comparator | The patients will receive calverial grafts, to reconstruct the deficient maxillary ridge Receives: Procedure: Autogenous bone augmentation |
| Control group: | Active comparator | The patients will receive iliac crestgrafts, to reconstruct the deficient maxillary ridge Receives: Procedure: Autogenous bone augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal bone gain
the study compares the horizontal bone gain of reconstructed maxillary alveolar ridges after being augmented with calverial and iliac crest bone grafts radiographically by millimeters
Measured: 6 months consolidation period
Secondary outcomes (1)
Immunohistochemical bone formation
the study compares the bone area percent of the consolidated calverial and iliac crest bone grafts
Measured: 6 months consolidation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start10 Aug 2023
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone AtrophyStudies 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
- Model description
- A) The Study group: The patients within the study group will receive mono-cortical bone block calvarial grafts B) The Control group: The patients within the control group will receive mono-cortical bone block iliac crest grafts,
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gibaly, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434441
- Sponsor's protocol ID
- 13
- Status last verified
- Jan 2025
- First submitted
- 23 May 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Assessment of Horizontal Bone Augmentation of Full Atrophic Maxillary Alveolar Ridges Using Calvarial Versus Iliac Crest Bone Blocks:
- ClinicalTrials.gov ID
- NCT06434441
- Acronym / sponsor ID
- 13
- Conditions
- Bone Atrophy
- Keywords
- Bone graft, Iliac crest blocks, Calverial bone blocks, Horizontal bone gain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 30 May 2024 (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 aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones
Detailed description
Although the calvarial bones represent a nearby donor site for maxillary augmentation of matching bone origin, the excessive volume of bone needed to reconstruct a severely deficient arch, the limited cancellous bone volume, and the arciform pattern of the skull cap that yield the curvatures of the harvested cortical blocks incompatible with the topography of the maxillary arch, all represent limitations for the calvarial graft.
The anterior iliac crest is frequently used for free bone grafting by being subcutaneous and generous to afford ample bone blocks of favorable curvatures. However, the minute cortical overlay and its endochondral origin contribute to excessive graft resorption. Pikos et al. demonstrated that a reasonable amount of graft resorption could occur with atraumatic surgical intervention and intimate graft fixation.
This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A) The Study group: The patients within the study group will receive mono-cortical bone block calvarial grafts B) The Control group: The patients within the control group will receive mono-cortical bone block iliac crest grafts,
| Arm | Type | Receives |
|---|---|---|
| Study group: | Active comparator | Procedure: Autogenous bone augmentationThe patients will receive calverial grafts, to reconstruct the deficient maxillary ridge |
| Control group: | Active comparator | Procedure: Autogenous bone augmentationThe patients will receive iliac crestgrafts, to reconstruct the deficient maxillary ridge |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with the clinical and radiographic interpretation of horizontal maxillary ridge deficiency of less than 5 mm
Key exclusion criteria (2 listed)
- Any previous maxillary reconstructive or dental implant treatment.
- Any local pathologic lesion or systemic disease that would affect the typical pattern of bone healing.
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 |
|---|---|---|
| Autogenous bone augmentationMaxillary alveolar bone reconstruction | Procedure or surgery | Control group:, Study group: |
Primary outcome
Horizontal bone gain
Time frame: 6 months consolidation period
the study compares the horizontal bone gain of reconstructed maxillary alveolar ridges after being augmented with calverial and iliac crest bone grafts radiographically by millimeters
1 secondary outcome
Immunohistochemical bone formation
Time frame: 6 months consolidation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous bone augmentation in people with Bone Atrophy, run by Beni-Suef University at 1 site in Egypt.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Jan 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amr Gibaly (01113336634, amrgibaly@dent.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal bone gain (time frame: 6 months consolidation period). 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 22 Jan 2025.