Maxillary Sinus Floor ElevationNCT03175458
Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement
A study testing sinus lift,implant placement,tenting and sinus lift,implant placement,bovine bone in people with Maxillary Sinus Floor Elevation, run by Cairo University at 1 site in Egypt.
Trial summary
30 recruited patients indicated for sinus membrane elevation with simultaneous implant placement. patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone graft after membrane elevation and insertion of the implants while the other group assigned for graft-less… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Maxillary Sinus Floor Elevation
- What is being tested?
- sinus lift,implant placement,tenting and sinus lift,implant placement,bovine bone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- 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 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement: Randomized Clinical Trial
30 recruited patients indicated for sinus membrane elevation with simultaneous implant placement. patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone graft after membrane elevation and insertion of the implants while the other group assigned for graft-less tenting technique after membrane elevation and insertion of the implant.
Read the detailed description
On the 2 groups a mucoperiosteal flap is elvated then a lateral wondow is created then sinus membrane is elevated then the implants are placed, in the control group deproteinized bovine bone graft substitute is placed in the sinus for augmentation while in the study group no bone graft is added inside the sinus( graftless tenting technique)
- Conditions
- Maxillary Sinus Floor Elevation
- Being tested
- sinus lift,implant placement,tenting, sinus lift,implant placement,bovine bone
- Keywords
- tenting, grafting, implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sinus lift,implant placement,tentingProcedure or surgery
elevation of the sinus membrane then insertion of the implants without any bone graft material( graft-less) for augmentation
sinus lift,implant placement,bovine boneProcedure or surgery
sinus membrane elevation then placement of the implants together with deproteinized bovine bone substitute as a graft material for augmentation
| Study group | Role | What they receive |
|---|---|---|
| sinus lift,implant placement,tenting | Experimental | elevation of the sinus membrane with simultaneous implant placement without the use of any bone graft material(tenting technique) Receives: Procedure: sinus lift,implant placement,tenting |
| sinus lift,implant placement,bovine bone | Active comparator | elevation of the sinus membrane with simultaneous implant placement together with deproteinized bovine bone graft substitute for augmentation Receives: Procedure: sinus lift,implant placement,bovine bone |
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 the osstell device
Measured: will be measured intraoperatively immediately after insertion of the implants and will be measure one more time 6 months after the 1st operation at the time of exposure of the implants
height of bone gained or lost around the implants
two cone beam computed tomography(CBCT) will be taken for the patient, one immediate postoperative and the other 6 months after the operation then the height of bone gained or lost around the implants will be assessed by superimposing the same section in the two CBCTS.
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study startJul 2016
- Primary completionJul 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 Floor ElevationStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Fouad Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175458
- Sponsor's protocol ID
- cebc.cu
- Status last verified
- Jun 2017
- First submitted
- 17 May 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schnederian Membrane Elevation and Augmentation With Deproteinized Bovine Bone [Tutu-gen Bone] Versus Graft Less Tenting Technique With Simultaneous Implant Placement: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03175458
- Acronym / sponsor ID
- cebc.cu
- Conditions
- Maxillary Sinus Floor Elevation
- Keywords
- tenting, grafting, implant placement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 5 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.
30 recruited patients indicated for sinus membrane elevation with simultaneous implant placement. patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone graft after membrane elevation and insertion of the implants while the other group assigned for graft-less tenting technique after membrane elevation and insertion of the implant.
Detailed description
On the 2 groups a mucoperiosteal flap is elvated then a lateral wondow is created then sinus membrane is elevated then the implants are placed, in the control group deproteinized bovine bone graft substitute is placed in the sinus for augmentation while in the study group no bone graft is added inside the sinus( graftless tenting technique)
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,tenting | Experimental | Procedure: sinus lift,implant placement,tentingelevation of the sinus membrane with simultaneous implant placement without the use of any bone graft material(tenting technique) |
| sinus lift,implant placement,bovine bone | Active comparator | Procedure: sinus lift,implant placement,bovine boneelevation of the sinus membrane with simultaneous implant placement together with deproteinized bovine bone graft substitute for augmentation |
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 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,tentingelevation of the sinus membrane then insertion of the implants without any bone graft material( graft-less) for augmentation | Procedure or surgery | sinus lift,implant placement,tenting |
| sinus lift,implant placement,bovine bonesinus membrane elevation then placement of the implants together with deproteinized bovine bone substitute as a graft material for augmentation | Procedure or surgery | sinus lift,implant placement,bovine bone |
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 intraoperatively immediately after insertion of the implants and will be measure one more time 6 months after the 1st operation at the time of exposure of the implants
height of bone gained or lost around the implants
Time frame: 6 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Maxillary Sinus Floor Elevation
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation
Recruiting
Evaluation of Lateral Sinus Floor Elevation Using Xenograft Versus L-PRF Block Combined With Xenograft
Sinus Floor Augmentation, Maxillary Sinus Floor Elevation
Not yet recruitingObservational study
Clinical Efficacy of Different Maxillary Sinus Floor Elevation Procedures
Maxillary Sinus Floor Elevation
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 sinus lift,implant placement,tenting and sinus lift,implant placement,bovine bone in people with Maxillary Sinus Floor Elevation, 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 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 5 Jun 2017. 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?
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 5 Jun 2017; AzTrials last refreshed its copy on 28 Oct 2026.