Horizontal Ridge DeficiencyNCT05286541
Buccal Cortical Separation and Lateralization for Horizontal Ridge Augmentation
A study testing Lateralized buccal cortex with xenograft and Lateralized buccal cortex with autogenous particulate in people with Horizontal Ridge Deficiency, run by Cairo University at 1 site in Egypt.
Trial summary
Cases with horizontal ridge deficiency less than what is possible for ridge splitting were recruited and the buccal cortex was totally separated and lateralized at the desired distance for augmentation Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- Lateralized buccal cortex with xenograft and Lateralized buccal cortex with autogenous particulate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2023to 20 Oct 2024
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- suffering only from posterior mandibular horizontal ridge deficiency and with adequate inter-arch space to accommodate the future restoration
Who cannot join
- Heavy smokers, diabetics, patients with bleeding problems, liver and kidney diseases, bone diseases that can affect bone healing, previous history of any ridge augmentation procedure in the posterior mandible, and those undergoing or planned for radiotherapy or chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative and Quantitative Assessment of Autogenous Versus Xenogenic Horizontal Ridge Augmentation After Mandibular Ridge-split with Buccal Cortical Lateralization: a Randomizedcontrolled Trial
Cases with horizontal ridge deficiency less than what is possible for ridge splitting were recruited and the buccal cortex was totally separated and lateralized at the desired distance for augmentation
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- Lateralized buccal cortex with xenograft, Lateralized buccal cortex with autogenous particulate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateralized buccal cortex with xenograftProcedure or surgery
the buccal cortex of the deficient ridge was separated and lateralized then fixed at the desired distance
Lateralized buccal cortex with autogenous particulateProcedure or surgery
lateralized buccal cortex with autogenous particulate
| Study group | Role | What they receive |
|---|---|---|
| Lateralized buccal cortex group with xenograft | Experimental | the buccal cortical bone was osteotomized and separated to be fixed in a lateralized position at the desired distance and the gap filled with Xenograft Receives: Procedure: Lateralized buccal cortex with xenograft |
| lateralized buccal cortex with autogenous particulate | Active comparator | the buccal cortex was lateralized same as in the interventional group but the gap filled with autogenous particulate Receives: Procedure: Lateralized buccal cortex with autogenous particulate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in horizontal bone gain
the net average bone gain (in millimeters) was calculated: by calculating the difference between the immediate post operative bone width measured on the Immediate CBCT and the six months bone width measured on the six months CBCT
Measured: six months after the operation
Secondary outcomes (1)
Bone area percent
histomorphometric analysis of core biopsies was done at the time of implant insertion to determine the bone area percent at the implant sites
Measured: Six months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start10 Oct 2023
- Primary completion20 Oct 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Horizontal Ridge DeficiencyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shawky, Cairo University
- Investigators
- Mohammed Atef, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286541
- Sponsor's protocol ID
- OMFS 3-3-9
- Status last verified
- Nov 2024
- First submitted
- 18 Feb 2022
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atef M, Shawky M, Mounir M, Gibaly A. Assessment of Modified Ridge Split With Autogenous Versus Xenogenic Augmentation: Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70046. doi: 10.1111/cid.70046.
PubMed 40342252
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Quantitative Assessment of Autogenous Versus Xenogenic Horizontal Ridge Augmentation After Mandibular Ridge-split with Buccal Cortical Lateralization: a Randomizedcontrolled Trial
- ClinicalTrials.gov ID
- NCT05286541
- Acronym / sponsor ID
- OMFS 3-3-9
- Conditions
- Horizontal Ridge Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 18 Mar 2022 (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.
Cases with horizontal ridge deficiency less than what is possible for ridge splitting were recruited and the buccal cortex was totally separated and lateralized at the desired distance for augmentation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lateralized buccal cortex group with xenograft | Experimental | Procedure: Lateralized buccal cortex with xenograftthe buccal cortical bone was osteotomized and separated to be fixed in a lateralized position at the desired distance and the gap filled with Xenograft |
| lateralized buccal cortex with autogenous particulate | Active comparator | Procedure: Lateralized buccal cortex with autogenous particulatethe buccal cortex was lateralized same as in the interventional group but the gap filled with autogenous particulate |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- suffering only from posterior mandibular horizontal ridge deficiency and with adequate inter-arch space to accommodate the future restoration
Key exclusion criteria (1 listed)
- Heavy smokers, diabetics, patients with bleeding problems, liver and kidney diseases, bone diseases that can affect bone healing, previous history of any ridge augmentation procedure in the posterior mandible, and those undergoing or planned for radiotherapy or chemotherapy
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 |
|---|---|---|
| Lateralized buccal cortex with xenograftthe buccal cortex of the deficient ridge was separated and lateralized then fixed at the desired distance | Procedure or surgery | Lateralized buccal cortex group with xenograft |
| Lateralized buccal cortex with autogenous particulatelateralized buccal cortex with autogenous particulate | Procedure or surgery | lateralized buccal cortex with autogenous particulate |
Primary outcome
Change in horizontal bone gain
Time frame: six months after the operation
the net average bone gain (in millimeters) was calculated: by calculating the difference between the immediate post operative bone width measured on the Immediate CBCT and the six months bone width measured on the six months CBCT
1 secondary outcome
Bone area percent
Time frame: Six months after the operation
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 3 Dec 2024.
- Derived from this study: PubMed 40342252Atef M, Shawky M, Mounir M, Gibaly A. Assessment of Modified Ridge Split With Autogenous Versus Xenogenic Augmentation: Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Jun;27(3):e70046. doi: 10.1111/cid.70046.
Related trials for Horizontal Ridge Deficiency
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Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
Recruiting
Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
Alveolar Bone Loss, Alveolar Ridge Deficiency
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.
Mohammed Atef, PhD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateralized buccal cortex with xenograft and Lateralized buccal cortex with autogenous particulate in people with Horizontal Ridge Deficiency, run by Cairo 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 1 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 3 Dec 2024. 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?
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?
Change in horizontal bone gain (time frame: six months after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05286541, which also lists 1 linked publication.
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 3 Dec 2024.