Maxillary Sinus AugmentationNCT03184857
Open Maxillary Sinus Augmentation Using Different Types of Bone Particles
A study testing open maxillary sinus lifting in people with Maxillary Sinus Augmentation, run by Cairo University at 1 site in Egypt.
Trial summary
Two stage sinus lifting using Nano hydroxyapatite particles [Nanostreams] versus Deprotenized bovine bone [Tutogen] : Randomized clinical trial. comparing between Height of new bone formation, Bone area percent( Histomorphometric) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Maxillary Sinus Augmentation
- What is being tested?
- open maxillary sinus lifting
- 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
- 1 Jul 2017to 30 Sep 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- sinus pathology
- heavy smokers
- patients with systemic disease uncontrolled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Stage Sinus Lifting Using Nano Hydroxyapatite Particles [Nanostreams] Versus Deprotenized Bovine Bone [Tutogen] : Randomized Clinical Trial.
Two stage sinus lifting using Nano hydroxyapatite particles [Nanostreams] versus Deprotenized bovine bone [Tutogen] : Randomized clinical trial.
comparing between Height of new bone formation, Bone area percent( Histomorphometric)
- Conditions
- Maxillary Sinus Augmentation
- Being tested
- open maxillary sinus lifting
- Keywords
- maxillary sinus, augmentation, bovine bone, Nano hydroxy appatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open maxillary sinus liftingProcedure or surgery
biopsy of the region 6 months later
| Study group | Role | What they receive |
|---|---|---|
| two stage sinus lifting using bovine bone particles | Active comparator | Open maxillary sinus lifting will be done with sinus augmentation using bovine bone particles Receives: Procedure: open maxillary sinus lifting |
| two sage sinus lifting using Nano HA bone particles | Experimental | Open maxillary sinus lifting will be done with sinus augmentation using Nano HA bone particles Receives: Procedure: open maxillary sinus lifting |
What is being measured
The primary outcome is the main question the study is designed to answer.
histomorphometric analysis
histomorphometric analysis to measure new bone percent formation and residual bone graft percent
Measured: 6 months
Secondary outcomes (1)
new height of bone gained
CBCT 6 months postoperative to measure the new height of 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 posted14 Jun 2017
- Study start1 Jul 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maxillary Sinus AugmentationStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Nour-El deen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184857
- Sponsor's protocol ID
- Cebc.cairouniversity - 1025
- Status last verified
- Mar 2024
- First submitted
- 9 Jun 2017
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nour M, Shawky M, Abaas RA, Hakam M, Atef M. Two Stage Sinus Lifting Using Nanohydroxyapatite Particles Versus Deproteinized Bovine Bone: Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Feb;27(1):e13410. doi: 10.1111/cid.13410. Epub 2024 Oct 31.
PubMed 39478644
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Stage Sinus Lifting Using Nano Hydroxyapatite Particles [Nanostreams] Versus Deprotenized Bovine Bone [Tutogen] : Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03184857
- Acronym / sponsor ID
- Cebc.cairouniversity - 1025
- Conditions
- Maxillary Sinus Augmentation
- Keywords
- maxillary sinus, augmentation, bovine bone, Nano hydroxy appatite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 14 Jun 2017 (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.
Two stage sinus lifting using Nano hydroxyapatite particles [Nanostreams] versus Deprotenized bovine bone [Tutogen] : Randomized clinical trial.
comparing between Height of new bone formation, Bone area percent( Histomorphometric)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| two stage sinus lifting using bovine bone particles | Active comparator | Procedure: open maxillary sinus liftingOpen maxillary sinus lifting will be done with sinus augmentation using bovine bone particles |
| two sage sinus lifting using Nano HA bone particles | Experimental | Procedure: open maxillary sinus liftingOpen maxillary sinus lifting will be done with sinus augmentation using Nano HA bone particles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (3 listed)
- sinus pathology
- heavy smokers
- patients with systemic disease uncontrolled
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 |
|---|---|---|
| open maxillary sinus liftingbiopsy of the region 6 months later | Procedure or surgery | two sage sinus lifting using Nano HA bone particles, two stage sinus lifting using bovine bone particles |
Primary outcome
histomorphometric analysis
Time frame: 6 months
histomorphometric analysis to measure new bone percent formation and residual bone graft percent
1 secondary outcome
new height of bone gained
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 2 Apr 2024.
- Derived from this study: PubMed 39478644Nour M, Shawky M, Abaas RA, Hakam M, Atef M. Two Stage Sinus Lifting Using Nanohydroxyapatite Particles Versus Deproteinized Bovine Bone: Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Feb;27(1):e13410. doi: 10.1111/cid.13410. Epub 2024 Oct 31.
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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 open maxillary sinus lifting in people with Maxillary Sinus Augmentation, 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 1 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 2 Apr 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?
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?
histomorphometric analysis (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 NCT03184857, which also lists 1 linked publication.
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 2 Apr 2024.