Maxillary Sinus LiftNCT03177876
Sinus Lift With Hydroxyapatite Nano Particles Versus Tenting Technique
A study testing sinus lift implant placement Hydroxyapatite Nano particles and sinus lift implant placement tenting in people with Maxillary Sinus Lift, run by Cairo University.
Trial summary
twenty recruited patients indicated for sinus augmentation and immediate implant placement will be divided into two groups (10 in each of the two groups), to compare bone formation and implant stability after shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles [Nanostreams] or… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Maxillary Sinus Lift
- What is being tested?
- sinus lift implant placement Hydroxyapatite Nano particles and sinus lift implant placement tenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm of residual ridge as per MISCH criteria
- Both sexes
Who cannot join
- Sinus pathology
- Heavy smokers more than 20 cigarettes per day
- Patients with systemic disease that may affect normal healing
About this study
Official title: Schneiderian Membrane Elevation and Augmentation With Hydroxyapatite Nano Particles [ Nano Streams ] Versus Graft Less Tenting Technique With Simultaneous Implant Placement: Randomized Clinical Trial
twenty recruited patients indicated for sinus augmentation and immediate implant placement will be divided into two groups (10 in each of the two groups), to compare bone formation and implant stability after shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles [Nanostreams] or augmentation with graft less tenting technique with simultaneous implant placement.
- Conditions
- Maxillary Sinus Lift
- Being tested
- sinus lift implant placement Hydroxyapatite Nano particles, sinus lift implant placement tenting
- Keywords
- tenting Hydroxyapetite nano particles implant immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinus lift implant placement Hydroxyapatite Nano particlesProcedure or surgery
shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles with simultaneous implant placement
sinus lift implant placement tentingProcedure or surgery
shneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement
| Study group | Role | What they receive |
|---|---|---|
| sinus lift implant placement Hydroxyapatite Nano particles | Experimental | shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles [Nanostreams] with simultaneous implant placement Receives: Procedure: sinus lift implant placement Hydroxyapatite Nano particles |
| sinus lift implant placement tenting | Active comparator | shneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement Receives: Procedure: sinus lift implant placement tenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
evaluation of post operative complications in terms of pain and edema using patient pain chart
Measured: 7 days post operative
Secondary outcomes (2)
implant stability
measurement of the implant stability using osstell device
Measured: will be measured intra-operative after implant insertion and will be measured one more time 6 months after the first operation at the time of implant exposure
height of bone gain or loss around the implant
two cone beam CT will be taken for the patients, one immediate post operative and the other 6 months post-operative then the amount of bone gained or loss will be assessed by superimposing the same section in the two cone beam CT
Measured: 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study startJul 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus LiftStudies 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Khaled Shehata Faraag, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177876
- Sponsor's protocol ID
- cebc.cairo university
- Status last verified
- Jun 2017
- First submitted
- 19 May 2017
- Last updated
- 6 Jun 2017
- 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 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schneiderian Membrane Elevation and Augmentation With Hydroxyapatite Nano Particles [ Nano Streams ] Versus Graft Less Tenting Technique With Simultaneous Implant Placement: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03177876
- Acronym / sponsor ID
- cebc.cairo university
- Conditions
- Maxillary Sinus Lift
- Keywords
- tenting Hydroxyapetite nano particles implant immediate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 6 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.
twenty recruited patients indicated for sinus augmentation and immediate implant placement will be divided into two groups (10 in each of the two groups), to compare bone formation and implant stability after shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles [Nanostreams] or augmentation with graft less tenting technique with simultaneous implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sinus lift implant placement Hydroxyapatite Nano particles | Experimental | Procedure: sinus lift implant placement Hydroxyapatite Nano particlesshneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles [Nanostreams] with simultaneous implant placement |
| sinus lift implant placement tenting | Active comparator | Procedure: sinus lift implant placement tentingshneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with atrophic maxilla and pneumatization of the maxillary sinus with residual bone height at least 5mm of residual ridge as per MISCH criteria
- Both sexes
Key exclusion criteria (3 listed)
- Sinus pathology
- Heavy smokers more than 20 cigarettes per day
- Patients with systemic disease that may affect normal healing
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 |
|---|---|---|
| sinus lift implant placement Hydroxyapatite Nano particlesshneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles with simultaneous implant placement | Procedure or surgery | sinus lift implant placement Hydroxyapatite Nano particles |
| sinus lift implant placement tentingshneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement | Procedure or surgery | sinus lift implant placement tenting |
Primary outcome
patient satisfaction
Time frame: 7 days post operative
evaluation of post operative complications in terms of pain and edema using patient pain chart
2 secondary outcomes
implant stability
Time frame: will be measured intra-operative after implant insertion and will be measured one more time 6 months after the first operation at the time of implant exposure
height of bone gain or loss around the implant
Time frame: 6 months post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Individual participant dataSharing planned: Yes
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Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
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Endoscopic-Assisted Versus Conventional Crestal Sinus Lift
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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 sinus lift implant placement Hydroxyapatite Nano particles and sinus lift implant placement tenting in people with Maxillary Sinus Lift, run by Cairo University.
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 2 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: status not confirmed, as of the sponsor's last update on 6 Jun 2017. 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?
patient satisfaction (time frame: 7 days post operative). 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 6 Jun 2017.