Alveolar Bone ResorptionPhase 4Shell graftingNCT04324697
Radiographic and Histological Evaluation of Regenerated Bone After Grafting Using Allograft Shell and Autogenous Chips
A Phase 4 study testing Horizontal alveolar bone augmentation in people with Alveolar Bone Resorption, run by October 6 University at 1 site in Egypt.
Trial summary
The clinical cases in the present study described the khoury shell technique using an allograft plate and autogenous chips, for horizontal reconstruction of the anterior alveolar ridge in the esthetic zone. Without need to use autogenous bone graft techniques that are characterized by more aggressive surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Alveolar Bone Resorption
- What is being tested?
- Horizontal alveolar bone augmentation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Apr 2018to 5 Sep 2019
- Phase
- Phase 4
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with class IV of Cawood and Howell classification in the anterior maxilla.
- Males and females 18-50 years of age.
- Patients with adequate oral hygiene.
- Patients with healed sites for at least 6 months after tooth extraction.
- Patients with an inter-arch distance of at least 6 mm.
- Compliance with all requirements in the study and signing the informed consent.
Who cannot join
- Patients with diseases of the immune system or systemic disease affecting bone healing
- Patients who are chronic users of medications known to affect the periodontal status.
- Patients with history of intravenous and/or oral bisphosphonate use.
- Pathologic lesions or acute infection in the area of defect.
- Patients who are pregnant or lactating mothers.
- Heavy smokers who smoke more than 10 cigarettes a day.
Show all 9Show fewer
- Patients with poor oral hygiene that are not amenable to motivation and improvement.
- Patients with history of irradiation of the head and neck region.
- Vulnerable patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Anterior Alveolar Ridge Reconstruction With Allogenic Bone Plate and Autogenous Cortical Bone Chips: A Radiographic and Histological Clinical Study
The clinical cases in the present study described the khoury shell technique using an allograft plate and autogenous chips, for horizontal reconstruction of the anterior alveolar ridge in the esthetic zone. Without need to use autogenous bone graft techniques that are characterized by more aggressive surgery.
- Conditions
- Alveolar Bone Resorption
- Being tested
- Horizontal alveolar bone augmentation
- Keywords
- Allograft, Autogenous chips, Horizontal augmentation, Khoury shell technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizontal alveolar bone augmentationProcedure or surgery
Also called MAXGRAFT@Cortico - Botiss
Horizontal augmentation in anterior maxilla using allograft shell and autogenous chips with no need for a second surgical site
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar Bone quantity
Alveolar bone width by millimeters using Cone Beam Computed Tomography
Measured: 6 months
Secondary outcomes (1)
Alveolar Bone quality
Histological evaluation of status of regenerated bone vitality and remodeling
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start8 Apr 2018
- Primary completion1 Jul 2019
- Study completion5 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone ResorptionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Reconstruction of the localized deficient anterior maxilla using an allograft cortical bone plate, which was fixed at a distance from the alveolar ridge using two micro-screws, and the created gap between the allograft plate and the alveolar ridge was filled with autogenous cortical bone chips harvested intraorally using a bone scrapper.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Khalid Tarek Mohamed Karkar, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324697
- Sponsor's protocol ID
- OMS-2018-03M
- Acronym
- Shell grafting
- Status last verified
- Apr 2020
- First submitted
- 23 Mar 2020
- Last updated
- 9 Jun 2020
- Results posted
- 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 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anterior Alveolar Ridge Reconstruction With Allogenic Bone Plate and Autogenous Cortical Bone Chips: A Radiographic and Histological Clinical Study
- ClinicalTrials.gov ID
- NCT04324697
- Acronym / sponsor ID
- Shell grafting / OMS-2018-03M
- Conditions
- Alveolar Bone Resorption
- Keywords
- Allograft, Autogenous chips, Horizontal augmentation, Khoury shell technique
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 8 Apr 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 5 Sep 2019 (actual)
- First posted
- 27 Mar 2020 (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 clinical cases in the present study described the khoury shell technique using an allograft plate and autogenous chips, for horizontal reconstruction of the anterior alveolar ridge in the esthetic zone. Without need to use autogenous bone graft techniques that are characterized by more aggressive surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Reconstruction of the localized deficient anterior maxilla using an allograft cortical bone plate, which was fixed at a distance from the alveolar ridge using two micro-screws, and the created gap between the allograft plate and the alveolar ridge was filled with autogenous cortical bone chips harvested intraorally using a bone scrapper.
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with class IV of Cawood and Howell classification in the anterior maxilla.
- Males and females 18-50 years of age.
- Patients with adequate oral hygiene.
- Patients with healed sites for at least 6 months after tooth extraction.
- Patients with an inter-arch distance of at least 6 mm.
Key exclusion criteria (9 listed)
- Patients with diseases of the immune system or systemic disease affecting bone healing
- Patients who are chronic users of medications known to affect the periodontal status.
- Patients with history of intravenous and/or oral bisphosphonate use.
- Pathologic lesions or acute infection in the area of defect.
- Patients who are pregnant or lactating mothers.
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 |
|---|---|---|
| Horizontal alveolar bone augmentationAlso: MAXGRAFT@Cortico - BotissHorizontal augmentation in anterior maxilla using allograft shell and autogenous chips with no need for a second surgical site | Procedure or surgery | – |
Primary outcome
Alveolar Bone quantity
Time frame: 6 months
Alveolar bone width by millimeters using Cone Beam Computed Tomography
1 secondary outcome
Alveolar Bone quality
Time frame: 7 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 9 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Alveolar Bone Resorption
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
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The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
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Enrolling by invitation
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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 Phase 4 study testing Horizontal alveolar bone augmentation in people with Alveolar Bone Resorption, run by October 6 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 6 inclusion and 9 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 9 Jun 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Alveolar Bone quantity (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 9 Jun 2020.