Maxillary Sinus LiftNCT03731650
Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths
A study testing maxillary sinus lift in people with Maxillary Sinus Lift, run by Cairo University.
Trial summary
twenty recruited patients indicated for sinus augmentation and simultaneous implant placement will be divided into two groups (10 in each of the groups).to evaluate \& compare bone formation \& implant stability after shneiderian membrane elevation and augmentation with graft less tenting technique with different… 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?
- maxillary sinus lift
- 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
- 1 Jan 2019to 15 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with atrophic maxilla \& pneumatized maxillary sinus with residual bone height at least 4mm of residual ridge
- both sexes
Who cannot join
- patients with systematic diseases that may affect normal healing
- sinus pathology
- heavy smokers more than 20 cigarettes per day
Trial locations and contacts
No sites are listed yet.
About this study
twenty recruited patients indicated for sinus augmentation and simultaneous implant placement will be divided into two groups (10 in each of the groups).to evaluate \& compare bone formation \& implant stability after shneiderian membrane elevation and augmentation with graft less tenting technique with different implant lengths.
group one will receive 8mm implant lenght while group two will receive 10mm implants.
- Conditions
- Maxillary Sinus Lift
- Being tested
- maxillary sinus lift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maxillary sinus liftProcedure or surgery
non grafted maxillary sinus floor augmentation with simultaneous implant placement
| Study group | Role | What they receive |
|---|---|---|
| active comparator | Experimental | Not described Receives: Procedure: maxillary sinus lift |
| placebo | Experimental | Not described Receives: Procedure: maxillary sinus lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
height of gained bone
two cone beam CT will be done for the patients, one immediate post operative \& the other 6 months post operative then the amount of gained bone will be assessed by superimposing the same section in the two cone beam CT.
Measured: 6 months post operative
Secondary outcomes (1)
implant stability
measurement of the implant stability using OSSTELL device.
Measured: will be measured intra operative after implant insertion and will be measured once more 6 months post operative after the first operation at the time of implant exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion15 Aug 2019 (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, Ahmed Abdulnasser, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731650
- Sponsor's protocol ID
- aaali.cairo university
- Status last verified
- Nov 2018
- First submitted
- 12 Sep 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths
- ClinicalTrials.gov ID
- NCT03731650
- Acronym / sponsor ID
- aaali.cairo university
- Conditions
- Maxillary Sinus Lift
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 15 Aug 2019 (estimated)
- First posted
- 6 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.
twenty recruited patients indicated for sinus augmentation and simultaneous implant placement will be divided into two groups (10 in each of the groups).to evaluate \& compare bone formation \& implant stability after shneiderian membrane elevation and augmentation with graft less tenting technique with different implant lengths.
group one will receive 8mm implant lenght while group two will receive 10mm implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active comparator | Experimental | Procedure: maxillary sinus lift |
| placebo | Experimental | Procedure: maxillary sinus lift |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient with atrophic maxilla \& pneumatized maxillary sinus with residual bone height at least 4mm of residual ridge
- both sexes
Key exclusion criteria (3 listed)
- patients with systematic diseases that may affect normal healing
- sinus pathology
- heavy smokers more than 20 cigarettes per day
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 |
|---|---|---|
| maxillary sinus liftnon grafted maxillary sinus floor augmentation with simultaneous implant placement | Procedure or surgery | active comparator, placebo |
Primary outcome
height of gained bone
Time frame: 6 months post operative
two cone beam CT will be done for the patients, one immediate post operative \& the other 6 months post operative then the amount of gained bone will be assessed by superimposing the same section in the two cone beam CT.
1 secondary outcome
implant stability
Time frame: will be measured intra operative after implant insertion and will be measured once more 6 months post operative after the first operation at the time of implant exposure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing maxillary sinus lift 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 Nov 2018. 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?
Contact ahmed abdul nasser ali, BDS (00201115905965, ahmedabdulnasserali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
height of gained bone (time frame: 6 months 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 Nov 2018.