Horizontal Ridge DeficiencyNCT06529653
Ridge Splitting Using Autogenous Bone Wedge Versus the Conventional Intercortical Augmentation Technique in Horizontally Deficient Anterior Maxilla
A study testing autogenous bone wedge in people with Horizontal Ridge Deficiency, run by Cairo University at 1 site in Egypt.
Trial summary
The current study aimed to evaluate both the quality and quantity of gained and maintained bone width after ridge splitting utilizing autogenic bone wedges versus mixed bone particles for horizontal ridge augmentation in the anterior esthetic zone. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- autogenous bone wedge
- 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
- 30 Oct 2022to 30 Dec 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients possessed partially edentulous anterior maxillary ridge with the following criteria
- The anterior maxillary vertical dimension was more than ten mm measured from the alveolar crest to the basal bone of the maxilla.
- The horizontal alveolar dimension varies from 3-5 mm at the crest and 6-8 mm at the basal part of the ridge measured from the labial cortex to the lingual cortex.
- All patients were free from any medical conditions that may affect bone healing .
- No local pathosis that may interfere with bone healing.
- No previous grafting procedures at the indicated edentulous ridge.
- -
Who cannot join
- 1- Patients suffering from any systemic disease that may affect bone healing. 2- Patients with less than 3mm labio palatal alveolar ridge width. 3- Ridge with inadequate vertical bone height. 4- Presence of any local pathosis that may interfere with bone healing. 5- Patients unable to continue the whole follow up.
- -
Trial locations and contacts
1 site in 1 country.
Mohamed Omara, PHD contact
Egypt1 site, 1 recruiting
- Recruiting
oral and maxillo facial Surgery Department; Faculty of dentistry, Cairo University.
Cairo
yasmin ahmed, B.D.S, 01065273456
About this study
Official title: Ridge Splitting Using Autogenous Bone Wedge Versus the Conventional Intercortical Augmentation Technique in Horizontally Deficient Anterior Maxilla A Randomized Clinical Trial
The current study aimed to evaluate both the quality and quantity of gained and maintained bone width after ridge splitting utilizing autogenic bone wedges versus mixed bone particles for horizontal ridge augmentation in the anterior esthetic zone.
Read the detailed description
This randomized clinical study included 20 patients with a horizontally deficient ridge in the esthetic region. Two groups were divided according to the type of intercortical bone graft used after ridge splitting: 10 patients for each. (The intervention group) had grafting with autogenous bone wedges harvested from the chin, and (the control group) had mixed (autogenic and xenogenic) bone particles.
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- autogenous bone wedge
- Keywords
- ridge splitting, bone wedge, mixed bone particles, horizontally deficient ridge, aesthetic zone, ridge augmentation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autogenous bone wedgeProcedure or surgery
autogenous bone block harvested from chin and adjusted to be wedged intercortical in split ridge
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Other | the group using an autogenous bone wedge harvested from the chin interpositioned between split cortices in the anterior maxilla to manage the horizontal deficiency of the ridge. Receives: Procedure: autogenous bone wedge |
| control group | Other | the group used mixed autogenic and xenogenic bone particles that interposed between split cortices in anterior maxilla to manage the horizontal deficiency of the ridge Receives: Procedure: autogenous bone wedge |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone width in (mm) by cone beam pre, immediate post operative and 6 months postoperative
after ridge augmentation in both groups, the bone width will be measured immediately postoperatively and 6 months postoperatively with cone beam and the measurements of the three intervals (pre-, immediate and 6 months postoperatively) will be compared in both groups to evaluate the amount of gained and maintained bone width
Measured: 6 months
Secondary outcomes (1)
percentage of areas of new bone (%)
The harvested core biopsies would be stained with H\&E and Massons trichrome stain and be microscopically examined to determine percentage areas of newly formed bone
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start30 Oct 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdel Salam Ibrahim Omara, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529653
- Sponsor's protocol ID
- ridge splitting
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Atef M, Osman AH, Hakam M. Autogenous interpositional block graft vs onlay graft for horizontal ridge augmentation in the mandible. Clin Implant Dent Relat Res. 2019 Aug;21(4):678-685. doi: 10.1111/cid.12809. Epub 2019 Jul 1.
PubMed 31260166Omara M, Mekhemer S, Mansour S, Ahmed Y. Ridge splitting using autogenous bone wedge versus the conventional intercortical augmentation technique in horizontally deficient anterior maxilla: a randomized clinical trial. BMC Oral Health. 2025 Jun 21;25(1):955. doi: 10.1186/s12903-025-06345-z.
PubMed 40544250
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Splitting Using Autogenous Bone Wedge Versus the Conventional Intercortical Augmentation Technique in Horizontally Deficient Anterior Maxilla A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06529653
- Acronym / sponsor ID
- ridge splitting
- Conditions
- Horizontal Ridge Deficiency
- Keywords
- ridge splitting, bone wedge, mixed bone particles, horizontally deficient ridge, aesthetic zone, ridge augmentation.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 31 Jul 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 current study aimed to evaluate both the quality and quantity of gained and maintained bone width after ridge splitting utilizing autogenic bone wedges versus mixed bone particles for horizontal ridge augmentation in the anterior esthetic zone.
Detailed description
This randomized clinical study included 20 patients with a horizontally deficient ridge in the esthetic region. Two groups were divided according to the type of intercortical bone graft used after ridge splitting: 10 patients for each. (The intervention group) had grafting with autogenous bone wedges harvested from the chin, and (the control group) had mixed (autogenic and xenogenic) bone particles.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Other | Procedure: autogenous bone wedgethe group using an autogenous bone wedge harvested from the chin interpositioned between split cortices in the anterior maxilla to manage the horizontal deficiency of the ridge. |
| control group | Other | Procedure: autogenous bone wedgethe group used mixed autogenic and xenogenic bone particles that interposed between split cortices in anterior maxilla to manage the horizontal deficiency of the ridge |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- All patients possessed partially edentulous anterior maxillary ridge with the following criteria
- All patients were free from any medical conditions that may affect bone healing .
- No local pathosis that may interfere with bone healing.
- No previous grafting procedures at the indicated edentulous ridge.
- -
Key exclusion criteria (2 listed)
- 1- Patients suffering from any systemic disease that may affect bone healing. 2- Patients with less than 3mm labio palatal alveolar ridge width. 3- Ridge with inadequate vertical bone height. 4- Presence of any local pathosis that may interfere with bone healing. 5- Patients unable to continue the whole follow up.
- -
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 wedgeautogenous bone block harvested from chin and adjusted to be wedged intercortical in split ridge | Procedure or surgery | control group, intervention group |
Primary outcome
bone width in (mm) by cone beam pre, immediate post operative and 6 months postoperative
Time frame: 6 months
after ridge augmentation in both groups, the bone width will be measured immediately postoperatively and 6 months postoperatively with cone beam and the measurements of the three intervals (pre-, immediate and 6 months postoperatively) will be compared in both groups to evaluate the amount of gained and maintained bone width
1 secondary outcome
percentage of areas of new bone (%)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Background: PubMed 31260166Atef M, Osman AH, Hakam M. Autogenous interpositional block graft vs onlay graft for horizontal ridge augmentation in the mandible. Clin Implant Dent Relat Res. 2019 Aug;21(4):678-685. doi: 10.1111/cid.12809. Epub 2019 Jul 1.
- Derived from this study: PubMed 40544250Omara M, Mekhemer S, Mansour S, Ahmed Y. Ridge splitting using autogenous bone wedge versus the conventional intercortical augmentation technique in horizontally deficient anterior maxilla: a randomized clinical trial. BMC Oral Health. 2025 Jun 21;25(1):955. doi: 10.1186/s12903-025-06345-z.
- Related InfoLink provided by the sponsor.
Related trials for Horizontal Ridge Deficiency
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
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Shell Technique for Implant Site Development
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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.
Mohamed Omara, PHD contact
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 wedge 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 7 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: status not confirmed, as of the sponsor's last update on 31 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yasmin ahmed, B.D.S (01065273456, yasmin.ahmed@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone width in (mm) by cone beam pre, immediate post operative and 6 months postoperative (time frame: 6 months). 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 NCT06529653, which also lists 2 linked publications.
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 31 Jul 2024.