Tooth LossPhase 4NCT02449707
Evaluation of a Lateral Window Technique Augmentation for Maxillary Sinus Using Ultrasound Activated Pins
A Phase 4 study testing Lateral Window Technique Augmentation for Maxillary Sinus, Ultrasound activated resorbable poly-D-L-lactide pins and Purus® Cancellous Allograft in people with Tooth Loss, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
Trial summary
Ultrasound activated pins have been used for the promotion of bone healing in combination with biodegradable membranes during bone grafting procedures. In the jaws, these pins have been successfully tested for both maxillary and mandibular ridge augmentaton. Read more about this study
- Who is it for?
- Ages 45 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Lateral Window Technique Augmentation for Maxillary Sinus, Ultrasound activated resorbable poly-D-L-lactide pins and Purus® Cancellous Allograft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2015to Aug 2016
- Phase
- Phase 4
- 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 45 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Loss of upper permanent molar on both right and left side
- Require Bilateral Maxillary Sinus Augmentation
- Consent to partipate in the study
Who cannot join
- History of Diabetes Mellitus (including patients who are controlled with oral hypoglyceamic drugs)
- Uncontrolled Hypertensive patients with three consecutive diastolic readings of over 90mmHg
- History of Osteoporosis
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Riyadh Colleges of Dentistry and Pharmacy
Riyadh
Sharat C Pani, MDS, sharat@riyadh.edu.sa
Sharat C Pani, MDS
About this study
Official title: Evaluation of a Lateral Window Technique Augmentation for Maxillary Sinus Lift Using Ultrasound Activated Resorbable Poly-D-L-lactide Pins in Maxillary Sinus Lift - a Split Mouth Randomized Control Trial
Ultrasound activated pins have been used for the promotion of bone healing in combination with biodegradable membranes during bone grafting procedures. In the jaws, these pins have been successfully tested for both maxillary and mandibular ridge augmentaton. However, the usefulness of these pins in maxillary sinus lift procedures has not been tested. This study aims to use a bilateral split mouth design to compare the bone formation, healing and post-operative complications after the use of ultrasonic guided pins in a lateral window maxillary sinus augmentation procedure in comparison to lateral window maxillary sinus augmentation procedure procedure performed without the use of these pins.
Read the detailed description
The study proposes to use a prospective split mouth crossover randomized control trial design to study the success of implant placement in cases with sinus lift procedures performed using the Sonic Weld® (KLS-Martin GmbH , Mulheim, Germany) ultrasound guided bone welding system with a membrane (Resorb X Membrane) on one side, and placement of Biomend collagen membrane to stabilize the graft
Patient selection:
20 patients requiring bilateral maxillary sinus lift procedure (40 procedures) will be selected from the patients reporting for implant placement to both the Riyadh Colleges of Dentistry and Pharmacy and the Riyadh Dental Center, King Saud Medical City.
Graft Placement:
Each patient will receive both the pin stabilized and the conventional graft placement procedures with standardized allografts (Purus® Cancellous Allograft?) on both sides of the maxilla. The grafts will be placed using the lateral window technique. The patients will be randomly assigned into either those who receive the pin first (Group A) or those who receive the conventional technique (using collagen membranes) first (Group B). The patients will have a one week gap between the sinus lift on the right and left sides.
Evaluations of the sinus lift procedure:
The sinus lift will be evaluated clinically radiographically and histologically using previously established criteria. Cone Beam CTs (Gallelios Comfort plus, Sirona Dental, Salzburg, Austria) will be taken preoperatively and at three month intervals to help assess the osseous outcomes of the graft.
At the end of one year the site will be evaluated clinically for the placement of implants. At the time of placement of the implant a trephine biopsy will be performed and H\&E staining will be used to determine the histological outcomes of the graft procedure.
Statistical Analysis:
The paired t test will be used to compare the thickness of bone before and after the completion of the sinus lift procedure. The multiple measures paired ANOVA will be used to compare the thickness of bone at each follow up vist.
The student's t test will be used to compare the thickness of bone between the two types of sinus lift procedure.
The chi-square test will be used to compare differences (if any) in the histological patterns obtained at the end of the study.
- Conditions
- Tooth Loss
- Being tested
- Lateral Window Technique Augmentation for Maxillary Sinus, Ultrasound activated resorbable poly-D-L-lactide pins, Purus® Cancellous Allograft, Resorb X Membrane, Biomend
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral Window Technique Augmentation for Maxillary SinusProcedure or surgery
Maxillary sinus augmentation will be performed using the lateral window technique
Ultrasound activated resorbable poly-D-L-lactide pinsDevice
Also called Sonic Weld
The titanium membrane placed during the maxillary sinus augmentation procedure will be stabilized using ultrasound activated resorbable poly-D-L-lactide pins
Purus® Cancellous AllograftDevice
Allograft material placed in the sinus to acheive sinus augmentation
Resorb X MembraneDevice
The membrane placed over the graft material before placement of the ultrasound activated pins
BiomendDevice
Collagen healing membrane placed over the graft material on the side where no ultrasound activated pins are being used
Cone Beam CT image of the SinusProcedure or surgery
Cone beam CT will used to assess the thickness of bone formation after the placement of the graft
Trephine BiopsyProcedure or surgery
Trephine Biopsy will be performed at the time of the placement of implant to study the quality of bone formed
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Lateral Window Technique Augmentation for Maxillary Sinus without the use of Ultrasound activated resorbable poly-D-L-lactide pins for the stabilization of membrane. Placement of Purus® Cancellous Allograft, stabilized by Biomend ™ Collagen membrane. Cone Beam CT image of the sinus will be taken to evaluate the bone formation. Trephine Biopsy will be performed after 1 year, at the time of placement of implant to check the quality of bone formed. Receives: Procedure: Lateral Window Technique Augmentation for Maxillary Sinus; Device: Purus® Cancellous Allograft; Device: Biomend; Procedure: Cone Beam CT image of the Sinus; Procedure: Trephine Biopsy |
| Ultrasonic Pins | Experimental | Lateral Window Technique Augmentation for Maxillary Sinus with the use of Ultrasound activated resorbable poly-D-L-lactide pins for the stabilization of the Purus® Cancellous Allograft, and Resorb X Membrane.Cone Beam CT image of the sinus will be taken to evaluate the bone formation. Trephine Biopsy will be performed after 1 year, at the time of placement of implant to check the quality of bone formed. Receives: Procedure: Lateral Window Technique Augmentation for Maxillary Sinus; Device: Ultrasound activated resorbable poly-D-L-lactide pins; Device: Purus® Cancellous Allograft; Device: Resorb X Membrane; Procedure: Cone Beam CT image of the Sinus; Procedure: Trephine Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone thickness (in mm)
Measured: Change from Baseline thickness in 6 months
Secondary outcomes (2)
Change in Post-operative pain - as reported on a Visual Analog Scale (VAS)
Measured: Change from baseline VAS in 6 months
Bone Quality - Measured by the type of bone observed on the trephine biopsy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Colleges of Dentistry and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud Medical City
- Responsible party
- Principal investigator, Dr Sharat Pani, Riyadh Colleges of Dentistry and Pharmacy
- Investigators
- Bishi AlGarni, MSc, Study chair, Riyadh Colleges of Dentistry and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449707
- Sponsor's protocol ID
- FRP/2014/109
- Status last verified
- May 2015
- First submitted
- 14 May 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Lateral Window Technique Augmentation for Maxillary Sinus Lift Using Ultrasound Activated Resorbable Poly-D-L-lactide Pins in Maxillary Sinus Lift - a Split Mouth Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02449707
- Acronym / sponsor ID
- FRP/2014/109
- Conditions
- Tooth Loss
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riyadh Colleges of Dentistry and PharmacyUniversity, hospital or other
- Collaborators
- King Saud Medical City
- Study start
- Apr 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 20 May 2015 (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.
Ultrasound activated pins have been used for the promotion of bone healing in combination with biodegradable membranes during bone grafting procedures. In the jaws, these pins have been successfully tested for both maxillary and mandibular ridge augmentaton. However, the usefulness of these pins in maxillary sinus lift procedures has not been tested. This study aims to use a bilateral split mouth design to compare the bone formation, healing and post-operative complications after the use of ultrasonic guided pins in a lateral window maxillary sinus augmentation procedure in comparison to lateral window maxillary sinus augmentation procedure procedure performed without the use of these pins.
Detailed description
The study proposes to use a prospective split mouth crossover randomized control trial design to study the success of implant placement in cases with sinus lift procedures performed using the Sonic Weld® (KLS-Martin GmbH , Mulheim, Germany) ultrasound guided bone welding system with a membrane (Resorb X Membrane) on one side, and placement of Biomend collagen membrane to stabilize the graft
Patient selection:
20 patients requiring bilateral maxillary sinus lift procedure (40 procedures) will be selected from the patients reporting for implant placement to both the Riyadh Colleges of Dentistry and Pharmacy and the Riyadh Dental Center, King Saud Medical City.
Graft Placement:
Each patient will receive both the pin stabilized and the conventional graft placement procedures with standardized allografts (Purus® Cancellous Allograft?) on both sides of the maxilla. The grafts will be placed using the lateral window technique. The patients will be randomly assigned into either those who receive the pin first (Group A) or those who receive the conventional technique (using collagen membranes) first (Group B). The patients will have a one week gap between the sinus lift on the right and left sides.
Evaluations of the sinus lift procedure:
The sinus lift will be evaluated clinically radiographically and histologically using previously established criteria. Cone Beam CTs (Gallelios Comfort plus, Sirona Dental, Salzburg, Austria) will be taken preoperatively and at three month intervals to help assess the osseous outcomes of the graft.
At the end of one year the site will be evaluated clinically for the placement of implants. At the time of placement of the implant a trephine biopsy will be performed and H\&E staining will be used to determine the histological outcomes of the graft procedure.
Statistical Analysis:
The paired t test will be used to compare the thickness of bone before and after the completion of the sinus lift procedure. The multiple measures paired ANOVA will be used to compare the thickness of bone at each follow up vist.
The student's t test will be used to compare the thickness of bone between the two types of sinus lift procedure.
The chi-square test will be used to compare differences (if any) in the histological patterns obtained at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Lateral Window Technique Augmentation for Maxillary Sinus, Device: Purus® Cancellous Allograft, Device: Biomend, Procedure: Cone Beam CT image of the Sinus, Procedure: Trephine BiopsyLateral Window Technique Augmentation for Maxillary Sinus without the use of Ultrasound activated resorbable poly-D-L-lactide pins for the stabilization of membrane. Placement of Purus® Cancellous Allograft, stabilized by Biomend ™ Collagen membrane. Cone Beam CT image of the sinus will be taken to evaluate the bone formation. Trephine Biopsy will be performed after 1 year, at the time of placement of implant to check the quality of bone formed. |
| Ultrasonic Pins | Experimental | Procedure: Lateral Window Technique Augmentation for Maxillary Sinus, Device: Ultrasound activated resorbable poly-D-L-lactide pins, Device: Purus® Cancellous Allograft, Device: Resorb X Membrane, Procedure: Cone Beam CT image of the Sinus, Procedure: Trephine BiopsyLateral Window Technique Augmentation for Maxillary Sinus with the use of Ultrasound activated resorbable poly-D-L-lactide pins for the stabilization of the Purus® Cancellous Allograft, and Resorb X Membrane.Cone Beam CT image of the sinus will be taken to evaluate the bone formation. Trephine Biopsy will be performed after 1 year, at the time of placement of implant to check the quality of bone formed. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Loss of upper permanent molar on both right and left side
- Require Bilateral Maxillary Sinus Augmentation
- Consent to partipate in the study
Key exclusion criteria (3 listed)
- History of Diabetes Mellitus (including patients who are controlled with oral hypoglyceamic drugs)
- Uncontrolled Hypertensive patients with three consecutive diastolic readings of over 90mmHg
- History of Osteoporosis
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 |
|---|---|---|
| Lateral Window Technique Augmentation for Maxillary SinusMaxillary sinus augmentation will be performed using the lateral window technique | Procedure or surgery | Control, Ultrasonic Pins |
| Ultrasound activated resorbable poly-D-L-lactide pinsAlso: Sonic WeldThe titanium membrane placed during the maxillary sinus augmentation procedure will be stabilized using ultrasound activated resorbable poly-D-L-lactide pins | Device | Ultrasonic Pins |
| Purus® Cancellous AllograftAllograft material placed in the sinus to acheive sinus augmentation | Device | Control, Ultrasonic Pins |
| Resorb X MembraneThe membrane placed over the graft material before placement of the ultrasound activated pins | Device | Ultrasonic Pins |
| BiomendCollagen healing membrane placed over the graft material on the side where no ultrasound activated pins are being used | Device | Control |
| Cone Beam CT image of the SinusCone beam CT will used to assess the thickness of bone formation after the placement of the graft | Procedure or surgery | Control, Ultrasonic Pins |
| Trephine BiopsyTrephine Biopsy will be performed at the time of the placement of implant to study the quality of bone formed | Procedure or surgery | Control, Ultrasonic Pins |
Primary outcome
Change in bone thickness (in mm)
Time frame: Change from Baseline thickness in 6 months
2 secondary outcomes
Change in Post-operative pain - as reported on a Visual Analog Scale (VAS)
Time frame: Change from baseline VAS in 6 months
Bone Quality - Measured by the type of bone observed on the trephine biopsy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
Bishi AlGarni, MSc study chair
Riyadh Colleges of Dentistry and Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lateral Window Technique Augmentation for Maxillary Sinus, Ultrasound activated resorbable poly-D-L-lactide pins and Purus® Cancellous Allograft in people with Tooth Loss, run by Riyadh Colleges of Dentistry and Pharmacy at 1 site in Saudi Arabia.
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 3 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 20 May 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 Saudi Arabia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Sharat Pani, MDS (+966544981300, sharat@riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone thickness (in mm) (time frame: Change from Baseline thickness in 6 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 20 May 2015.