CystectomyPhase 1/2GBRNCT00454038
Study of Collagen Membrane in Guided Bone Regeneration
A Phase 1/2 study testing HYPRO SORB F in people with Cystectomy and Segmental Growing of Alveolar Tissue, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
Trial summary
The main purpose of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystectomy, Segmental Growing of Alveolar Tissue, Sinus Lift
- What is being tested?
- HYPRO SORB F
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to May 2009
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cystectomy
- Segmental growing of alveolar tissue
- Lifting of the sinus bottom
- Root amputation
- Apicoectomy
- Filling of the alveolus after resections in prosthetic surgical practice
- Periimplantitis
- Maxillofacial surgery
Who cannot join
- Inside bone fractures when acrylate adhesives are applied.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Baruch Padeh Medical Center, Poriya
Tiberias
Emad K Ailabouni, D.M.D, (972)46652429, emadniss@netvision.net.il
Rabab R Jarjoura, D.M.D, (972)504358785, rababrj@yahoo.com
About this study
Official title: Preliminary Study of Hypro-Sorb® F Bilayer Bioabsorbable Membrane for Guided Tissue and Bone Regeneration
The main purpose of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR.
Read the detailed description
Guided bone regeneration is a procedure used in dentistry for the reconstruction of osseous defects around teeth, dental implants, and prior to implant placement. The main function of the membrane barrier in GBR is to mechanically prevent the undesirable penetration of epithelial cells and fibroblasts to the bone defect area, creating a secluded space where bone regeneration may occur. Resorbable and non-resorbable membranes have been used in GBR. While non resorbable membranes require another surgical procedure for removing the membrane after the healing period, the resorbable membranes have the advantage of transmitting tissue fluids, excluding undesirable cell penetration and sparing an additional unwanted surgical procedure. The aim of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR.
- Conditions
- Cystectomy, Segmental Growing of Alveolar Tissue, Sinus Lift, Root Amputation and Apicoectomy, Periimplantitis
- Being tested
- HYPRO SORB F
- Keywords
- cystectomy, augmentation, sinus, amputation, implant
- Medical subject headings
- Peri-Implantitis, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYPRO SORB FDevice
resorbable, double layered, collagen membrane
What is being measured
The primary outcome is the main question the study is designed to answer.
expected
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startJun 2007
- Primary completionJan 2008 (estimated)
- Study completionMay 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CystectomyStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Investigators
- Alabuni Emad, Study chair, The Baruch Padeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454038
- Sponsor's protocol ID
- ae-01.CTIL
- Acronym
- GBR
- Status last verified
- Jan 2009
- First submitted
- 28 Mar 2007
- Last updated
- 10 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of Hypro-Sorb® F Bilayer Bioabsorbable Membrane for Guided Tissue and Bone Regeneration
- ClinicalTrials.gov ID
- NCT00454038
- Acronym / sponsor ID
- GBR / ae-01.CTIL
- Conditions
- Cystectomy, Segmental Growing of Alveolar Tissue, Sinus Lift, Root Amputation and Apicoectomy, Periimplantitis
- Keywords
- cystectomy, augmentation, sinus, amputation, implant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Jun 2007
- Primary completion
- Jan 2008 (estimated)
- Study completion
- May 2009 (estimated)
- First posted
- 29 Mar 2007 (estimated)
- 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.
The main purpose of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR.
Detailed description
Guided bone regeneration is a procedure used in dentistry for the reconstruction of osseous defects around teeth, dental implants, and prior to implant placement. The main function of the membrane barrier in GBR is to mechanically prevent the undesirable penetration of epithelial cells and fibroblasts to the bone defect area, creating a secluded space where bone regeneration may occur. Resorbable and non-resorbable membranes have been used in GBR. While non resorbable membranes require another surgical procedure for removing the membrane after the healing period, the resorbable membranes have the advantage of transmitting tissue fluids, excluding undesirable cell penetration and sparing an additional unwanted surgical procedure. The aim of this study is to investigate the efficacy of Hypro-Sorb® F, a bilayered bioabsorbable membrane in inducing bone regeneration in different dental procedures requiring GBR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Cystectomy
- Segmental growing of alveolar tissue
- Lifting of the sinus bottom
- Root amputation
- Apicoectomy
Key exclusion criteria (1 listed)
- Inside bone fractures when acrylate adhesives are applied.
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 |
|---|---|---|
| HYPRO SORB Fresorbable, double layered, collagen membrane | Device | – |
Primary outcome
expected
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2009.
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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.
Alabuni Emad study chair
The Baruch Padeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HYPRO SORB F in people with Cystectomy and Segmental Growing of Alveolar Tissue, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
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 8 inclusion and 1 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 10 Jul 2009. 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 Israel. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Emad K Ailabouni, D.M.D ((972)46652429, emadniss@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expected (time frame: 2 years). 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 10 Jul 2009.