Alveolar Bone LossNCT05198011
Three-Dimensional Printed Customized Titanium Mesh for Mandibular Augmentation
A study testing 3D customized Titanium Mesh (Study) in people with Alveolar Bone Loss, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Completely or partially edentulous patients suffer from resorption of the alveolar bone, they always seek rehabilitation which becomes challenging. Alveolar ridge augmentation is widely done now to offer these patients functional and esthetic restoration. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- 3D customized Titanium Mesh (Study)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 30 Apr 2020
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will have a posterior mandibular atrophic ridge
- Distance between the crest of the ridge and the superior border of the inferior alveolar canal will be from 5 mm to 7 m
- Adequate inter-arch space
Who cannot join
- Patients who have any uncontrolled systemic disease contraindicated to oral surgery ( Diabetes, hypertension, and patients under chemotherapy treatment )
- Patients who have any relevant bone disease.
- Patients who are smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mandibular Ridge Augmentation Using Three-Dimensional Printed Model for Customization of Titanium Mesh
Completely or partially edentulous patients suffer from resorption of the alveolar bone, they always seek rehabilitation which becomes challenging. Alveolar ridge augmentation is widely done now to offer these patients functional and esthetic restoration. Many techniques have been proposed to obtain good results of ridge augmentation. Titanium Mesh (TiMe) is widely used, also digital and computer-guided surgery now plays an important role to improve the techniques and results in ridge augmentation procedures.
- Conditions
- Alveolar Bone Loss
- Being tested
- 3D customized Titanium Mesh (Study), Conventional ridge augmentation (Control)
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D customized Titanium Mesh (Study)Procedure or surgery
approach for planning and augmenting atrophic posterior mandibular ridge using a pre-customized TiMe on a 3D model. The 3D surgical model will be virtually created from a cone-beam computed tomography (CBCT) and printed using Fused deposition modeling (FDM) machine. The 3D model will be then used to contour the TiMe in accordance with the needed amount of augmentation then will be used to help pack and contour the graft material.
Conventional ridge augmentation (Control)Procedure or surgery
the conventional technique of ridge augmentation using Titanium Mesh
| Study group | Role | What they receive |
|---|---|---|
| 3D mandibular ridge augmentation | Experimental | Not described Receives: Procedure: 3D customized Titanium Mesh (Study) |
| Conventional mandibular ridge augmentation | Active comparator | Not described Receives: Procedure: Conventional ridge augmentation (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone volume
Bone volume wa measured using CBCT
Measured: at baseline and 6 months
Operation time
Time of operation for each group will be calculated
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Oct 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198011
- Sponsor's protocol ID
- Augmentation_Maxillo
- Status last verified
- Jan 2022
- First submitted
- 4 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Ridge Augmentation Using Three-Dimensional Printed Model for Customization of Titanium Mesh
- ClinicalTrials.gov ID
- NCT05198011
- Acronym / sponsor ID
- Augmentation_Maxillo
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 20 Jan 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.
Completely or partially edentulous patients suffer from resorption of the alveolar bone, they always seek rehabilitation which becomes challenging. Alveolar ridge augmentation is widely done now to offer these patients functional and esthetic restoration. Many techniques have been proposed to obtain good results of ridge augmentation. Titanium Mesh (TiMe) is widely used, also digital and computer-guided surgery now plays an important role to improve the techniques and results in ridge augmentation procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D mandibular ridge augmentation | Experimental | Procedure: 3D customized Titanium Mesh (Study) |
| Conventional mandibular ridge augmentation | Active comparator | Procedure: Conventional ridge augmentation (Control) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients will have a posterior mandibular atrophic ridge
- Distance between the crest of the ridge and the superior border of the inferior alveolar canal will be from 5 mm to 7 m
- Adequate inter-arch space
Key exclusion criteria (3 listed)
- Patients who have any uncontrolled systemic disease contraindicated to oral surgery ( Diabetes, hypertension, and patients under chemotherapy treatment )
- Patients who have any relevant bone disease.
- Patients who are smokers
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 |
|---|---|---|
| 3D customized Titanium Mesh (Study)approach for planning and augmenting atrophic posterior mandibular ridge using a pre-customized TiMe on a 3D model. The 3D surgical model will be virtually created from a cone-beam computed tomography (CBCT) and printed using Fused deposition modeling (FDM) machine. The 3D model will be then used to contour the TiMe in accordance with the needed amount of augmentation then will be used to help pack and contour the graft material. | Procedure or surgery | 3D mandibular ridge augmentation |
| Conventional ridge augmentation (Control)the conventional technique of ridge augmentation using Titanium Mesh | Procedure or surgery | Conventional mandibular ridge augmentation |
Primary outcome
Change in bone volume
Time frame: at baseline and 6 months
Bone volume wa measured using CBCT
Operation time
Time frame: During the procedure
Time of operation for each group will be calculated
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 20 Jan 2022.
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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 3D customized Titanium Mesh (Study) in people with Alveolar Bone Loss, run by Hams Hamed Abdelrahman 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 3 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 20 Jan 2022. 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 bone volume (time frame: at baseline and 6 months). The study lists 2 primary outcomes in all. 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 20 Jan 2022.