Atrophic Anterior Maxillary RidgesNCT04075942
Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate
A study testing Atrophic Anterior Maxillary Ridges in people with Atrophic Anterior Maxillary Ridges, run by Manal Ahmed Hassan Ahmed.
Trial summary
Using customized Xenograft bone shell with mixture of autogenous and xenograft particulate in modified cortical shell technique. by 3D printed model from The CT scans segmentation by special software Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Anterior Maxillary Ridges
- What is being tested?
- Atrophic Anterior Maxillary Ridges
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Jan 2021
- 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- patients with atrophic Anterior Maxillary Ridges
Who cannot join
- Heavy smokers
- Uncontrolled diabetic patients.
- Pregnant patients. Psychiatric patient
- pathology related to bone.
About this study
Using customized Xenograft bone shell with mixture of autogenous and xenograft particulate in modified cortical shell technique. by 3D printed model from The CT scans segmentation by special software
Read the detailed description
Using customized Xenograft bone shell by 3D printed model from The CT scans segmentation by special software ( Mimics ) . All surgeries were performed by the same surgeon .
All surgical procedures were performed under strict aseptic conditions, all patients received infiltration local anesthesia (Articaine 4% 1:100 000 epinephrine).
a midcrestal incision was made in the anterior region using No. 15 blade. A full thickness mucoperiosteal flap was raised to expose the underlying alveolar ridge. The residual remaining bone in the area was minimal, with a maximum measured ridge thickness of 3 or 4 mm. 'To reconstruct the lost alveolar bone, an xenograft bone shell approximately 1 to 2 mm thick was shaped, after 3D print the bone shell were fixed to the buccal defect, using screws . 'The space between the plate and the existing palatal bone wall was then filled using a combination of autograft bone chips and xenograft bone particles
. Periosteal releasing incision is done to obtain stress free primary closure. The flap will then be closed using interrupted 4/0 resorbable sutures. After 4 month will insert implant . After 3 month will insert final restoration which will be mostly PMF .
- Conditions
- Atrophic Anterior Maxillary Ridges
- Being tested
- Atrophic Anterior Maxillary Ridges
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrophic Anterior Maxillary RidgesProcedure or surgery
Use of modified cortical shell technique grafted with customized Xenograft bone shell
| Study group | Role | What they receive |
|---|---|---|
| Atrophic Anterior Maxillary Ridges participants | Other | Using customized Xenograft bone shell with equal mixture of autogenous and xenograft particulate bone as a graft with the modified cortical shell technique, with atrophic anterior maxilla with less than 5 mm Bucco-lingual Receives: Procedure: Atrophic Anterior Maxillary Ridges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bucco-lingual bone width gain.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study startJan 2021 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Anterior Maxillary RidgesStudies 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manal Ahmed Hassan Ahmed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manal Ahmed Hassan Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075942
- Sponsor's protocol ID
- PER 6-3-1
- Status last verified
- Jan 2021
- First submitted
- 28 Aug 2019
- Last updated
- 26 Jan 2021
- 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 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate
- ClinicalTrials.gov ID
- NCT04075942
- Acronym / sponsor ID
- PER 6-3-1
- Conditions
- Atrophic Anterior Maxillary Ridges
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Manal Ahmed Hassan AhmedUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 3 Sep 2019 (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.
Using customized Xenograft bone shell with mixture of autogenous and xenograft particulate in modified cortical shell technique. by 3D printed model from The CT scans segmentation by special software
Detailed description
Using customized Xenograft bone shell by 3D printed model from The CT scans segmentation by special software ( Mimics ) . All surgeries were performed by the same surgeon .
All surgical procedures were performed under strict aseptic conditions, all patients received infiltration local anesthesia (Articaine 4% 1:100 000 epinephrine).
a midcrestal incision was made in the anterior region using No. 15 blade. A full thickness mucoperiosteal flap was raised to expose the underlying alveolar ridge. The residual remaining bone in the area was minimal, with a maximum measured ridge thickness of 3 or 4 mm. 'To reconstruct the lost alveolar bone, an xenograft bone shell approximately 1 to 2 mm thick was shaped, after 3D print the bone shell were fixed to the buccal defect, using screws . 'The space between the plate and the existing palatal bone wall was then filled using a combination of autograft bone chips and xenograft bone particles
. Periosteal releasing incision is done to obtain stress free primary closure. The flap will then be closed using interrupted 4/0 resorbable sutures. After 4 month will insert implant . After 3 month will insert final restoration which will be mostly PMF .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrophic Anterior Maxillary Ridges participants | Other | Procedure: Atrophic Anterior Maxillary RidgesUsing customized Xenograft bone shell with equal mixture of autogenous and xenograft particulate bone as a graft with the modified cortical shell technique, with atrophic anterior maxilla with less than 5 mm Bucco-lingual |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with atrophic Anterior Maxillary Ridges
Key exclusion criteria (4 listed)
- Heavy smokers
- Uncontrolled diabetic patients.
- Pregnant patients. Psychiatric patient
- pathology related to bone.
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 |
|---|---|---|
| Atrophic Anterior Maxillary RidgesUse of modified cortical shell technique grafted with customized Xenograft bone shell | Procedure or surgery | Atrophic Anterior Maxillary Ridges participants |
Primary outcome
Bucco-lingual bone width gain.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Atrophic Anterior Maxillary Ridges in people with Atrophic Anterior Maxillary Ridges, run by Manal Ahmed Hassan Ahmed.
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 4 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 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Bucco-lingual bone width gain. (time frame: 4 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 26 Jan 2021.