Disorder of Maxillary SinusPhase 2NCT01735721
Comparative Study of Algipore and Decalcified Freeze-dried Bone Allograft in Open Maxillary Sinus Augmentation
A Phase 2 study testing Open Sinus Lift in people with Disorder of Maxillary Sinus and Maxillary Sinus Floor Augmentation, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of this study was the radiographic and clinical comparison of Algipore with decalcified freeze-dried bone allograft (DFDBA) in the open maxillary sinus lift technique using piezoelectric instruments. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Disorder of Maxillary Sinus, Maxillary Sinus Floor Augmentation
- What is being tested?
- Open Sinus Lift
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Mar 2009to Jun 2010
- Phase
- Phase 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- physically healthy patients
- ridge bone height of less than 5 mm
Who cannot join
- any past medical history of systemic or localized diseases that were contraindications for sinus or implant surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Algipore and Decalcified Freeze-dried Bone Allograft in Open Maxillary Sinus Elevation Using Piezoelectric Surgery
The aim of this study was the radiographic and clinical comparison of Algipore with decalcified freeze-dried bone allograft (DFDBA) in the open maxillary sinus lift technique using piezoelectric instruments.
Read the detailed description
Vertical and horizontal bone resorption of the alveolar ridge are common in edentulous jaws. In the distal area of the maxilla, an adequate bone volume is often lacking because of the proximity of the sinus cavities to crestal bone. Sinus floor augmentation is an established way of increasing the height and volume of bone in the posterior region of the maxilla, which increase the stability of dental implants. For this purpose various materials, including auto grafts, allografts, alloplasts, and xenografts have been used.
- Being tested
- Open Sinus Lift
- Keywords
- Sinus Floor Augmentation, Bone Transplantation, Bone Substitute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Sinus LiftProcedure or surgery
A crestal incision was made on the mucosa of the edentulous ridge. The flap was elevated carefully and extended labially to expose the bone. A vertical releasing incision was made in the mesial end of the flap as needed. The mucoperiosteal flap was extended to expose the alveolar ridge and the lateral wall of the maxillary sinus. Then, a window was prepared using the piezoelectric device (Mectron, Italy); the Schneiderian membrane was then elevated conservatively according to the technique described by Vercellotti (2001).
The sinus membrane was meticulously detached and pushed superiorly to allow for the placement of bone graft material.
| Study group | Role | What they receive |
|---|---|---|
| Open Sinus Lift with DFDBA | Active comparator | In each patient, one sinus was chosen at random and filled with DFDBA (Tissue Regeneration Corporation, Iran). Receives: Procedure: Open Sinus Lift |
| Open Sinus Lift with Algipore | Experimental | The contra lateral sinus was filled with Algipore (Dentsply, USA). Receives: Procedure: Open Sinus Lift |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in bone height
Baseline and 9 months radiographs were scanned with an Agfa scanner at 1200 dpi with a 12-bit grayscale and stored in JPEG format. Changes in bone height were calculated in each case. Two reference points, one at the lowest part of the ridge crest and the other at the highest part of sinus floor, were selected in two radiographs (baseline and after 9 months) and their distance was calculated in 0.1mm scale using computer.
Measured: 9 months
Secondary outcomes (1)
Bone Density
Changes in radiographic density after sinus grafting were evaluated using densitometry.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Maxillary SinusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Moeintaghavi, Mashhad University of Medical Sciences
- Investigators
- Amir Moeintaghavi, DDS., Msc., Study director, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735721
- Sponsor's protocol ID
- 86319
- Status last verified
- Apr 2015
- First submitted
- 25 Nov 2012
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Algipore and Decalcified Freeze-dried Bone Allograft in Open Maxillary Sinus Elevation Using Piezoelectric Surgery
- ClinicalTrials.gov ID
- NCT01735721
- Acronym / sponsor ID
- 86319
- Keywords
- Sinus Floor Augmentation, Bone Transplantation, Bone Substitute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Nov 2012 (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 aim of this study was the radiographic and clinical comparison of Algipore with decalcified freeze-dried bone allograft (DFDBA) in the open maxillary sinus lift technique using piezoelectric instruments.
Detailed description
Vertical and horizontal bone resorption of the alveolar ridge are common in edentulous jaws. In the distal area of the maxilla, an adequate bone volume is often lacking because of the proximity of the sinus cavities to crestal bone. Sinus floor augmentation is an established way of increasing the height and volume of bone in the posterior region of the maxilla, which increase the stability of dental implants. For this purpose various materials, including auto grafts, allografts, alloplasts, and xenografts have been used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Sinus Lift with DFDBA | Active comparator | Procedure: Open Sinus LiftIn each patient, one sinus was chosen at random and filled with DFDBA (Tissue Regeneration Corporation, Iran). |
| Open Sinus Lift with Algipore | Experimental | Procedure: Open Sinus LiftThe contra lateral sinus was filled with Algipore (Dentsply, USA). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- physically healthy patients
- ridge bone height of less than 5 mm
Key exclusion criteria (1 listed)
- any past medical history of systemic or localized diseases that were contraindications for sinus or implant surgery
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 |
|---|---|---|
| Open Sinus LiftA crestal incision was made on the mucosa of the edentulous ridge. The flap was elevated carefully and extended labially to expose the bone. A vertical releasing incision was made in the mesial end of the flap as needed. The mucoperiosteal flap was extended to expose the alveolar ridge and the lateral wall of the maxillary sinus. Then, a window was prepared using the piezoelectric device (Mectron, Italy); the Schneiderian membrane was then elevated conservatively according to the technique described by Vercellotti (2001). The sinus membrane was meticulously detached and pushed superiorly to allow for the placement of bone graft material. | Procedure or surgery | Open Sinus Lift with Algipore, Open Sinus Lift with DFDBA |
Primary outcome
increase in bone height
Time frame: 9 months
Baseline and 9 months radiographs were scanned with an Agfa scanner at 1200 dpi with a 12-bit grayscale and stored in JPEG format. Changes in bone height were calculated in each case. Two reference points, one at the lowest part of the ridge crest and the other at the highest part of sinus floor, were selected in two radiographs (baseline and after 9 months) and their distance was calculated in 0.1mm scale using computer.
1 secondary outcome
Bone Density
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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.
Amir Moeintaghavi, DDS., Msc. study director
Mashhad University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Open Sinus Lift in people with Disorder of Maxillary Sinus and Maxillary Sinus Floor Augmentation, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 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: finished, as of the sponsor's last update on 8 Apr 2015. 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 Iran. 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
increase in bone height (time frame: 9 months). 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 8 Apr 2015.