Alveolar Bone GraftingNCT06727591
Evaluation of Horizontal Anterior Mandibular Augmentation With Split Bone Block Technique From the Chin
A study testing Split Bone Block Technique in people with Alveolar Bone Grafting, run by hossam samy mohamed saleh at 1 site in Egypt.
Trial summary
The aim of this study was to compare clinically and radiographically bone gain, healing of the surgical site, healing of the grafted bone and stability of the grafted area following horizontal ridge augmentation at anterior mandible using split bone block from the chin area. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Alveolar Bone Grafting
- What is being tested?
- Split Bone Block Technique
- 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 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with missing anterior mandibular teeth
- horizontal bone width < 5 mm
- Adequate zone of keratinized tissue
Who cannot join
- Presence of infection or periapical lesions in adjacent teeth
- Medically compromised patients with a condition that affect the procedure
- Insufficient inter-arch distance
- Bruxism or clenching
- Alcoholism
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to compare clinically and radiographically bone gain, healing of the surgical site, healing of the grafted bone and stability of the grafted area following horizontal ridge augmentation at anterior mandible using split bone block from the chin area.
- Conditions
- Alveolar Bone Grafting
- Being tested
- Split Bone Block Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split Bone Block TechniqueProcedure or surgery
An intraoral crestal incision with/out vertical arms was performed on alveolar ridge using blade no.15. After flap reflection, patroning the defect to help guide the area to be grafted from the donor site. At the chin area (donor site) unicortical cuts will be made at least 5 mm inferior to root tips, 5 mm superior to inferior border of mandible and 5 mm away from the mental foramen. The graft was luxated and split into two bone shells each 1 ~ 2 mm in thickness using disc. The bone shells and the donor site were scrapped for autogenous graft particles. Decortication of the recipient site. The graft was stabilised into the recipient site using two or more self tapping titanium screws placed midway corono-apical in the bone shell following the ridge contour. The autogenous particles were packed into the space between the split bone block and the ridge. Collagen sponge was used to cover the donor site. After 4 months the site was approached for implant placement using crestal incision
| Study group | Role | What they receive |
|---|---|---|
| Horizontal Ridge Augmentation with Split Bone Block | Experimental | Not described Receives: Procedure: Split Bone Block Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
It was assessed through a 10-point Visual Analogue Scale (VAS). The categories were as follows (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Measured: up to 2 weeks
Implant stability
Implant stability was measured using Osstell. Osstell measures the resonance frequency which indicated the implant stability. It has a scale from 1 to 100 where:
- <60 is considered low stability.
- 60 ~ 69 is considered intermediate stability.
- ≥ 70 is considered high stability
Measured: up to 3 months
Amount of horizontal bone gain
This was measured on cone beam computed tomography (CBCT) by comparing pre- and post-operative bone width at specific levels around the implant.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- 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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- hossam samy mohamed saleh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, hossam samy mohamed saleh, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727591
- Sponsor's protocol ID
- #8/2023
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saleh H, Eldibany R, Metawie D. Clinical and radiographic outcomes of horizontal auto-augmentation of the anterior mandible using a single-site surgical technique prior to delayed implant placement: a case series. BMC Oral Health. 2026 Jul 11;26(1):1243. doi: 10.1186/s12903-026-09134-4.
PubMed 42436440
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Horizontal Anterior Mandibular Augmentation With Split Bone Block Technique From the Chin
- ClinicalTrials.gov ID
- NCT06727591
- Acronym / sponsor ID
- #8/2023
- Conditions
- Alveolar Bone Grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- hossam samy mohamed salehUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 11 Dec 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.
The aim of this study was to compare clinically and radiographically bone gain, healing of the surgical site, healing of the grafted bone and stability of the grafted area following horizontal ridge augmentation at anterior mandible using split bone block from the chin area.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Horizontal Ridge Augmentation with Split Bone Block | Experimental | Procedure: Split Bone Block Technique |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient with missing anterior mandibular teeth
- horizontal bone width < 5 mm
- Adequate zone of keratinized tissue
Key exclusion criteria (6 listed)
- Presence of infection or periapical lesions in adjacent teeth
- Medically compromised patients with a condition that affect the procedure
- Insufficient inter-arch distance
- Bruxism or clenching
- Alcoholism
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 |
|---|---|---|
| Split Bone Block TechniqueAn intraoral crestal incision with/out vertical arms was performed on alveolar ridge using blade no.15. After flap reflection, patroning the defect to help guide the area to be grafted from the donor site. At the chin area (donor site) unicortical cuts will be made at least 5 mm inferior to root tips, 5 mm superior to inferior border of mandible and 5 mm away from the mental foramen. The graft was luxated and split into two bone shells each 1 ~ 2 mm in thickness using disc. The bone shells and the donor site were scrapped for autogenous graft particles. Decortication of the recipient site. The graft was stabilised into the recipient site using two or more self tapping titanium screws placed midway corono-apical in the bone shell following the ridge contour. The autogenous particles were packed into the space between the split bone block and the ridge. Collagen sponge was used to cover the donor site. After 4 months the site was approached for implant placement using crestal incision | Procedure or surgery | Horizontal Ridge Augmentation with Split Bone Block |
Primary outcome
Postoperative Pain
Time frame: up to 2 weeks
It was assessed through a 10-point Visual Analogue Scale (VAS). The categories were as follows (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Implant stability
Time frame: up to 3 months
Implant stability was measured using Osstell. Osstell measures the resonance frequency which indicated the implant stability. It has a scale from 1 to 100 where: * <60 is considered low stability. * 60 ~ 69 is considered intermediate stability. * ≥ 70 is considered high stability
Amount of horizontal bone gain
Time frame: up to 4 months
This was measured on cone beam computed tomography (CBCT) by comparing pre- and post-operative bone width at specific levels around the implant.
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 11 Dec 2024.
- Derived from this study: PubMed 42436440Saleh H, Eldibany R, Metawie D. Clinical and radiographic outcomes of horizontal auto-augmentation of the anterior mandible using a single-site surgical technique prior to delayed implant placement: a case series. BMC Oral Health. 2026 Jul 11;26(1):1243. doi: 10.1186/s12903-026-09134-4.
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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. 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 Split Bone Block Technique in people with Alveolar Bone Grafting, run by hossam samy mohamed saleh 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 3 inclusion and 6 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 11 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?
Postoperative Pain (time frame: up to 2 weeks). The study lists 3 primary outcomes in all. 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 NCT06727591, 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 11 Dec 2024.