Sinus Floor AugmentationNCT01771302
Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation
A study testing Bio-Oss and calcium phosphate ceramic in people with Sinus Floor Augmentation, run by Fundación Eduardo Anitua at 1 site in Spain.
Trial summary
This randomized clinical study investigates the efficiency of plasma rich in growth factors (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after the performance of lateral sinus floor elevation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinus Floor Augmentation
- What is being tested?
- Bio-Oss and calcium phosphate ceramic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2013to Apr 2014
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years
- Patients requiring implant prostheses oral rehabilitation.
- Patients with insufficient residual height in posterior maxilla requiring a sinus lift procedure to insert the implants
Who cannot join
- Not having complete the informed consent form.
- Sinusitis.
- Alcoholism.
- Suffering severe haematological disorder or disease.
- Be undergoing or having received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and / or anticoagulants, 30 days prior to the study inclusion.
- In usual treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or other anti-inflammatory drugs.
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- Background of chronic hepatitis or liver cirrhosis.
- Diabetes mellitus with poor metabolic control (glycosylated hemoglobin above 9%)
- Patients undergoing dialysis.
- Presence of malignant tumors, hemangiomas or angiomas in the extraction area.
- History of ischemic heart disease in the last year.
- Pregnancy or intention to become pregnant during the study follow-up period.
- Metabolic bone disease
- Patients taking bisphosphonates drugs both orally and intravenously.
- In general, any inability to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial on the Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation
This randomized clinical study investigates the efficiency of plasma rich in growth factors (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after the performance of lateral sinus floor elevation.
The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone formation regardless the type of bone graft.
- Conditions
- Sinus Floor Augmentation
- Being tested
- Bio-Oss, calcium phosphate ceramic
- Keywords
- PRGF-Endoret, Bone graft, Maxillary sinus, Vertical bone augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-OssDevice
It is a bone substitute of bovine origin
calcium phosphate ceramicDevice
It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature
| Study group | Role | What they receive |
|---|---|---|
| Bio-Oss | Active comparator | the xenograft is of bovine origin where the organic phase has been eliminated. Receives: Device: Bio-Oss |
| calcium phosphate ceramic | Experimental | is a calcium phosphate biomaterial Receives: Device: calcium phosphate ceramic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of newly-formed bone
The histomorphometrical analysis of the biopsies taken after 6 months of surgical intervention (time for dental implants insertion) will be performed to calculate the primary outcome
Measured: 6 months after surgical intervention
Secondary outcomes (6)
Bone density
This data will be measured on the cone-beam CT scanners obtained at baseline and after 6 months of healing
Measured: at baseline and after 6 months of intervention
Insertion torque
At the time of implant insertion and initial insertion torque will be registered
Measured: 6 months after surgical intervention
Percentage of residual graft
The histological analysis will determine the percentage of residual graft after 6 months of surgery.
Measured: 6 months after surgical intervention
Pain index
This will evaluate the intensity of pain the patient suffered due to the surgical intervention.
Measured: 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention
Healing index
This index will evaluate the soft tissue healing.
Measured: 7 days, 15 days and 1 month after surgical intervention
Infection
Notify the infection of the graft material
Measured: 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Floor AugmentationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Eduardo Anitua
- Sponsor type
- University, hospital or other
- Collaborators
- Biotechnology Institute IMASD
- Responsible party
- Sponsor
- Investigators
- Eduardo Anitua, MD, DDS, PhD, Principal investigator, Clinica Eduardo Anitua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771302
- Sponsor's protocol ID
- BTI-EC/12/Biomat
- Status last verified
- Jul 2015
- First submitted
- 15 Jan 2013
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on the Efficiency of PRGF-Endoret in Combination With a Bone Graft in Lateral Sinus Floor Elevation
- ClinicalTrials.gov ID
- NCT01771302
- Acronym / sponsor ID
- BTI-EC/12/Biomat
- Conditions
- Sinus Floor Augmentation
- Keywords
- PRGF-Endoret, Bone graft, Maxillary sinus, Vertical bone augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fundación Eduardo AnituaUniversity, hospital or other
- Collaborators
- Biotechnology Institute IMASD
- Study start
- Jan 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Jan 2013 (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.
This randomized clinical study investigates the efficiency of plasma rich in growth factors (PRGF-Endoret) in combination with bone grafts in the healing of bone and soft tissues after the performance of lateral sinus floor elevation.
The hypothesis of this study is that the use of PRGF-Endoret will produce similar bone formation regardless the type of bone graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-Oss | Active comparator | Device: Bio-Ossthe xenograft is of bovine origin where the organic phase has been eliminated. |
| calcium phosphate ceramic | Experimental | Device: calcium phosphate ceramicis a calcium phosphate biomaterial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years
- Patients requiring implant prostheses oral rehabilitation.
- Patients with insufficient residual height in posterior maxilla requiring a sinus lift procedure to insert the implants
Key exclusion criteria (15 listed)
- Not having complete the informed consent form.
- Sinusitis.
- Alcoholism.
- Suffering severe haematological disorder or disease.
- Be undergoing or having received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and / or anticoagulants, 30 days prior to the study inclusion.
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 |
|---|---|---|
| Bio-OssIt is a bone substitute of bovine origin | Device | Bio-Oss |
| calcium phosphate ceramicIt is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature | Device | calcium phosphate ceramic |
Primary outcome
Percentage of newly-formed bone
Time frame: 6 months after surgical intervention
The histomorphometrical analysis of the biopsies taken after 6 months of surgical intervention (time for dental implants insertion) will be performed to calculate the primary outcome
6 secondary outcomes
Bone density
Time frame: at baseline and after 6 months of intervention
Insertion torque
Time frame: 6 months after surgical intervention
Percentage of residual graft
Time frame: 6 months after surgical intervention
Pain index
Time frame: 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention
Healing index
Time frame: 7 days, 15 days and 1 month after surgical intervention
Infection
Time frame: 7 days, 15 days, 1 month, 2 months, 6 months and 12 months after surgical intervention
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 23 Aug 2021.
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The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
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Smart Scaffolds, Stronger Smiles Smarter Healing: AI-Boosted Multiphasic Scaffold Design for PDL Regeneration
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Closed Sinus Augmentation With a Calcium Phosphosilicate Putty
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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.
Eduardo Anitua, MD, DDS, PhD principal investigator
Clinica Eduardo Anitua
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-Oss and calcium phosphate ceramic in people with Sinus Floor Augmentation, run by Fundación Eduardo Anitua at 1 site in Spain.
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 15 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 23 Aug 2021. 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 Spain. 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?
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?
Percentage of newly-formed bone (time frame: 6 months after surgical intervention). 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 23 Aug 2021.