Bone LossNCT03734094
Custom-made Ceramic Barrier vs Titanium Mesh
A study testing Ceramic barrier and Titanium Mesh in people with Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
It is a comparative study between custom-made ceramic barrier and titanium mesh for augmentation of atrophic posterior mandible. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- Ceramic barrier and Titanium Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Jul 2018
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with atrophic posterior mandible
- Both sexes
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Who cannot join
- Untreated gingivitis
- Periodontitis
- Insufficient oral hygiene
- Previous radiation therapy
- Head and neck neoplasia
- Systemic disorders
Show all 11Show fewer
- Heavy smokers
- Bone pathology
- Psychiatric problems
- Emotional instability
- Unrealistic aesthetic demands
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Custom-made Ceramic Barrier and Titanium Mesh for Augmentation of Atrophic Posterior Mandible
It is a comparative study between custom-made ceramic barrier and titanium mesh for augmentation of atrophic posterior mandible.
- Conditions
- Bone Loss
- Being tested
- Ceramic barrier, Titanium Mesh
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceramic barrierDevice
The use of a ceramic barrier to induce bone formation during GBR
Titanium MeshDevice
The use of a titanium mesh to induce bone formation during GBR
| Study group | Role | What they receive |
|---|---|---|
| Ceramic Barrier | Experimental | The use of a ceramic barrier to induce bone formation during GBR Receives: Device: Titanium Mesh |
| Titanium mesh | Active comparator | The use of a titanium mesh to induce bone formation during GBR Receives: Device: Ceramic barrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone height
CBCT \& Three dimensional planning software to measure the height of bone gained in millimeters.
Measured: 6 months
Bone width
CBCT \& Three dimensional planning software to measure the width of bone gained in millimeters.
Measured: 6 months
Secondary outcomes (1)
Histomorphometric - bone area percent
Histomorphometric analysis of bone area percent
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 posted7 Nov 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed El Saharty, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734094
- Sponsor's protocol ID
- 737
- Status last verified
- Dec 2018
- First submitted
- 1 Nov 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Custom-made Ceramic Barrier and Titanium Mesh for Augmentation of Atrophic Posterior Mandible
- ClinicalTrials.gov ID
- NCT03734094
- Acronym / sponsor ID
- 737
- Conditions
- Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 7 Nov 2018 (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.
It is a comparative study between custom-made ceramic barrier and titanium mesh for augmentation of atrophic posterior mandible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ceramic Barrier | Experimental | Device: Titanium MeshThe use of a ceramic barrier to induce bone formation during GBR |
| Titanium mesh | Active comparator | Device: Ceramic barrierThe use of a titanium mesh to induce bone formation during GBR |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with atrophic posterior mandible
- Both sexes
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placement
Key exclusion criteria (11 listed)
- Untreated gingivitis
- Periodontitis
- Insufficient oral hygiene
- Previous radiation therapy
- Head and neck neoplasia
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 |
|---|---|---|
| Ceramic barrierThe use of a ceramic barrier to induce bone formation during GBR | Device | Titanium mesh |
| Titanium MeshThe use of a titanium mesh to induce bone formation during GBR | Device | Ceramic Barrier |
Primary outcome
Bone height
Time frame: 6 months
CBCT \& Three dimensional planning software to measure the height of bone gained in millimeters.
Bone width
Time frame: 6 months
CBCT \& Three dimensional planning software to measure the width of bone gained in millimeters.
1 secondary outcome
Histomorphometric - bone area percent
Time frame: 6 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 21 Dec 2018.
- Individual participant dataSharing planned: Yes
Related trials for Bone Loss
Not yet recruitingObservational study
3D-Printed Pelvic Models for Planning Complex Total Hip Arthroplasty
Developmental Dysplasia of the Hip, Acetabular Bone Loss
Not yet recruiting
Exercise and Fall Prevention for Fracture Reduction
Osteopenia, Osteoporosis
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
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 Ceramic barrier and Titanium Mesh in people with Bone Loss, 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 4 inclusion and 11 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 21 Dec 2018. 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?
Bone height (time frame: 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 21 Dec 2018.