Maxillary SinusNCT03252366
Maxillary Sinus Elevation and Simultaneous Implant Placement
A study testing GELFOAM and xenograft in people with Maxillary Sinus, run by Cairo University.
Trial summary
using gel foam [ absorbable gelatin ] in maxillary sinus elevation which act as a space maintainer and alternative to bone filler for new bone formation in the maxillary sinus and its advantages for patients undergoing maxillary sinus elevation with simultaneous implant placement as regards the implant stability and… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus
- What is being tested?
- GELFOAM and xenograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Sep 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Heavy smokers more than 20 cigarettes per day .
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems.
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
About this study
Official title: MAXILLARY SINUS ELEVATION USING GELFOAM (ABSORBABLE GELATIN) VERSUS XENOGRAFT (TUTOGEN) and SIMULTANEOUS IMPLANT PLACEMENT:Randomized Clinical Trial
using gel foam [ absorbable gelatin ] in maxillary sinus elevation which act as a space maintainer and alternative to bone filler for new bone formation in the maxillary sinus and its advantages for patients undergoing maxillary sinus elevation with simultaneous implant placement as regards the implant stability and amount of bone height gain compared to conventional maxillary sinus elevation by xenograft.
Read the detailed description
One of the main problem for posterior maxilla it becomes atrophic after extraction of the teeth and this followed by Pneumatization of the maxillary sinus, the atrophy of the alveolar process is a common reason for the limited availability of alveolar bone for implant placement in the posterior maxilla.
Numerous techniques designed to increase bone volume in the maxillary sinus region have been proposed. They were mostly based on the insertion of various materials into a void created between the sinus (Schneiderian) membrane and the bony walls of the maxillary sinus. (Sohn et al 2008) reported simultaneous placement of implants, and insertion of gelatin sponges demonstrate new bone formation through clinical and radiographic evaluations. New bone formation was verified by stabilization of the elevated sinus membrane from the tenting effect of placement of dental implants and absorbable gelatin sponge without any bone graft material. This study shows that there is great potential for new bone formation in the maxillary sinus without the use of additional bone grafts. Systemic review showed that the survival rate for implants utilizing xenografts was statistically the same as for implants placed in particulate autogenous bone grafts .
- Conditions
- Maxillary Sinus
- Being tested
- GELFOAM, xenograft
- Keywords
- MAXILLARY SINUS ELEVATION ,Simultaneous implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GELFOAMDevice
Also called (ABSORBABLE GELATIN)
- Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla.
- A diamond bur will be used to make a rectangular osteotomy.
- The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement.
- Implant stability will be measured by osteal device
- implant will be inserted with gelfoam (absorbable gelatin) for augmentation• The flap will then be copiously irrigated with saline in preparation for closure.
- The flap will then be closed using interrupted 4/0 resorbable sutures.
xenograftDevice
Also called TUTOGEN
- Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla.
- A diamond bur will be used to make a rectangular osteotomy.
- The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement.
- Implant stability will be measured by osteal device
- implants will be inserted with xenograft for augmentation.• The flap will then be copiously irrigated with saline in preparation for closure.
- The flap will then be closed using interrupted 4/0 resorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| GELFOAM (ABSORBABLE GELATIN) | Active comparator | Sterile Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic.
it act as a space maintainer and alternative to bone filler for new bone formation in the maxillary sinus. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids its effect appears to be more physical than the result of altering the blood clotting mechanism. When placed in soft tissues, GELFOAM is usually absorbed completely within four to six weeks, without inducing excessive scar tissue Receives: Device: GELFOAM |
| XENOGRAFT (TUTOGEN) | Active comparator | xenografts as a sinus bone replacement graft ,The osteoconductive properties of xenografts in human sinus grafting have been well documented. They are due to both their chemical composition and their macro and micro morphology.The efficacy of xenografts as a sinus bone replacement graft may be due to combination of factors. Foremost would be the osteoconductive capacity of xenografts. In addition, they supply minerals that are necessary for bone formation, their density provides stability to the graft and the implants placed in them, and this density persists long term due to the fact that these grafts do not completely resorb. Receives: Device: xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of bone gained:
using linear measurements from Cone beam computed tomography
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study startApr 2016
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary SinusStudies 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
- Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatma fawzy kandel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252366
- Sponsor's protocol ID
- MI.cairouniversity
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 17 Aug 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 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAXILLARY SINUS ELEVATION USING GELFOAM (ABSORBABLE GELATIN) VERSUS XENOGRAFT (TUTOGEN) and SIMULTANEOUS IMPLANT PLACEMENT:Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03252366
- Acronym / sponsor ID
- MI.cairouniversity
- Conditions
- Maxillary Sinus
- Keywords
- MAXILLARY SINUS ELEVATION ,Simultaneous implant placement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 17 Aug 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.
using gel foam [ absorbable gelatin ] in maxillary sinus elevation which act as a space maintainer and alternative to bone filler for new bone formation in the maxillary sinus and its advantages for patients undergoing maxillary sinus elevation with simultaneous implant placement as regards the implant stability and amount of bone height gain compared to conventional maxillary sinus elevation by xenograft.
Detailed description
One of the main problem for posterior maxilla it becomes atrophic after extraction of the teeth and this followed by Pneumatization of the maxillary sinus, the atrophy of the alveolar process is a common reason for the limited availability of alveolar bone for implant placement in the posterior maxilla.
Numerous techniques designed to increase bone volume in the maxillary sinus region have been proposed. They were mostly based on the insertion of various materials into a void created between the sinus (Schneiderian) membrane and the bony walls of the maxillary sinus. (Sohn et al 2008) reported simultaneous placement of implants, and insertion of gelatin sponges demonstrate new bone formation through clinical and radiographic evaluations. New bone formation was verified by stabilization of the elevated sinus membrane from the tenting effect of placement of dental implants and absorbable gelatin sponge without any bone graft material. This study shows that there is great potential for new bone formation in the maxillary sinus without the use of additional bone grafts. Systemic review showed that the survival rate for implants utilizing xenografts was statistically the same as for implants placed in particulate autogenous bone grafts .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GELFOAM (ABSORBABLE GELATIN) | Active comparator | Device: GELFOAMSterile Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic. it act as a space maintainer and alternative to bone filler for new bone formation in the maxillary sinus. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids its effect appears to be more physical than the result of altering the blood clotting mechanism. When placed in soft tissues, GELFOAM is usually absorbed completely within four to six weeks, without inducing excessive scar tissue |
| XENOGRAFT (TUTOGEN) | Active comparator | Device: xenograftxenografts as a sinus bone replacement graft ,The osteoconductive properties of xenografts in human sinus grafting have been well documented. They are due to both their chemical composition and their macro and micro morphology.The efficacy of xenografts as a sinus bone replacement graft may be due to combination of factors. Foremost would be the osteoconductive capacity of xenografts. In addition, they supply minerals that are necessary for bone formation, their density provides stability to the graft and the implants placed in them, and this density persists long term due to the fact that these grafts do not completely resorb. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Heavy smokers more than 20 cigarettes per day .
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems.
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
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 |
|---|---|---|
| GELFOAMAlso: (ABSORBABLE GELATIN)* Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla. * A diamond bur will be used to make a rectangular osteotomy. * The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement. * Implant stability will be measured by osteal device * implant will be inserted with gelfoam (absorbable gelatin) for augmentation• The flap will then be copiously irrigated with saline in preparation for closure. * The flap will then be closed using interrupted 4/0 resorbable sutures. | Device | GELFOAM (ABSORBABLE GELATIN) |
| xenograftAlso: TUTOGEN* Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla. * A diamond bur will be used to make a rectangular osteotomy. * The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement. * Implant stability will be measured by osteal device * implants will be inserted with xenograft for augmentation.• The flap will then be copiously irrigated with saline in preparation for closure. * The flap will then be closed using interrupted 4/0 resorbable sutures. | Device | XENOGRAFT (TUTOGEN) |
Primary outcome
Amount of bone gained:
Time frame: 6 month
using linear measurements from Cone beam computed tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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 GELFOAM and xenograft in people with Maxillary Sinus, 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 0 inclusion and 4 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 17 Aug 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?
Amount of bone gained: (time frame: 6 month). 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 17 Aug 2017; AzTrials last refreshed its copy on 1 Nov 2026.