Maxillary Sinus DiseasePhase 1NCT06071416
Biphasic Material With PRF in Lateral Sinus Floor Augmentation
A Phase 1 study testing Lateral sinus floor augmentation, Biphasic Calcium Phosphate and Injectable platlets rich fibrin in people with Maxillary Sinus Disease, run by Assiut University.
Trial summary
A lack of bone in the posterior maxilla, mainly resulting from the combination of alveolar bone resorption after tooth loss, pneumatization of the maxillary sinus, and periodontal disease, leads to increased difficulty during dental implant treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Maxillary Sinus Disease
- What is being tested?
- Lateral sinus floor augmentation, Biphasic Calcium Phosphate and Injectable platlets rich fibrin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2024to Apr 2024
- Phase
- Phase 1
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residual bone crest height < 5 mm and width≥6 mm in the planned implant site.
- Healed bone crest (at least 6 months elapsed from tooth loss/extraction);
Who cannot join
- Absolute medical contraindications to implant surgery such as uncontrolled diabetes mellitus, blood platelet disorders, serious osseous disorders, and cardiac arrhythmia; history of bone grafting in the posterior maxilla, immunocompromised patients, taking corticosteroids, taking aspirin before the procedure, positive history of chemotherapy and radiotherapy, and maxillary sinus pathologies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Lateral Approach Maxillary Sinus Floor Augmentation Using Biphasic Material Combined With Injectable Platelet Rich Fibrin- Randomized Clinical Trial
A lack of bone in the posterior maxilla, mainly resulting from the combination of alveolar bone resorption after tooth loss, pneumatization of the maxillary sinus, and periodontal disease, leads to increased difficulty during dental implant treatment.
The classic technique for maxillary sinus floor augmentation entails the preparation of the trap door to elevate the schneiderian membrane in the lateral sinus wall. it can be done either in a single stage with simultaneous implant placement or in two stages with delayed implant placement, depending on the available residual alveolar ridge height that necessary for implant primary stability.
The new compartment created between the floor of maxillary sinus and the elevated membrane was filled with either autogenous, allografts, xenograft or combination of them to maintain space for new bone formation. The disadvantages of such methods are high costs for grafting material, time consuming and high morbidity, because harvesting of bone grafts is needed.
Read the detailed description
Recently, a systematic review demonstrated the effectiveness of synthetic bone materials, including biphasic calcium phosphate (BCP), as substitutes for autogenous bone. BCP consists of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP). In contrast with stable HA, β-TCP is highly resorptive and is replaced by newly formed bone; therefore, the resorption rate of BCP could be influenced by the ratio of HA and β-TCP.
platelet-rich fibrin (PRF) was recently introduced as additional or replacement materials in bone augmentation procedures. The use of biologic mediators with osteoinductive properties has been considered to reduce the time interval and accelerate the formation of new bone. The strengths of PRF in reducing tissue inflammation, promoting the vascularization of bone tissue, accelerating new bone formation, and improving scaffold mechanics have been reported.
- Conditions
- Maxillary Sinus Disease
- Being tested
- Lateral sinus floor augmentation, Biphasic Calcium Phosphate, Injectable platlets rich fibrin
- Keywords
- sinus floor augmentation, biphasic calcium phosphate, PRF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral sinus floor augmentationProcedure or surgery
maxillary sinus floor augmentation by lateral approach
Biphasic Calcium PhosphateDrug
appliaction of BCP bone substitute
Injectable platlets rich fibrinProcedure or surgery
centrifuge 10 ml of patient blood to get I-PRF that applied to the bone substitute
| Study group | Role | What they receive |
|---|---|---|
| Group 1 BCP alone | Active comparator | Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application Receives: Procedure: Lateral sinus floor augmentation; Drug: Biphasic Calcium Phosphate |
| Group 2 BCP with I-PRF | Active comparator | Lateral bone augmentation with biphasic calcium phosphate BCP bone substitute application with addition of injectable platlet rich fibrin I-PRF Receives: Procedure: Lateral sinus floor augmentation; Drug: Biphasic Calcium Phosphate; Procedure: Injectable platlets rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical bone gain BG
Vertical bone gain (BG) 6 months after sinus augmentation in both height and density aspects by cone beam CT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start15 Feb 2024 (estimated)
- Primary completion15 Mar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I, patients undergo sinus lifting using bone substitute BCP alone. -Group II, patients who undergo sinus lifting using BCP with I-PRF.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alzahraa Alghriany, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071416
- Sponsor's protocol ID
- PRF in sinus augmentation
- Status last verified
- Jan 2024
- First submitted
- 1 Oct 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Lateral Approach Maxillary Sinus Floor Augmentation Using Biphasic Material Combined With Injectable Platelet Rich Fibrin- Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06071416
- Acronym / sponsor ID
- PRF in sinus augmentation
- Conditions
- Maxillary Sinus Disease
- Keywords
- sinus floor augmentation, biphasic calcium phosphate, PRF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 6 Oct 2023 (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.
A lack of bone in the posterior maxilla, mainly resulting from the combination of alveolar bone resorption after tooth loss, pneumatization of the maxillary sinus, and periodontal disease, leads to increased difficulty during dental implant treatment.
The classic technique for maxillary sinus floor augmentation entails the preparation of the trap door to elevate the schneiderian membrane in the lateral sinus wall. it can be done either in a single stage with simultaneous implant placement or in two stages with delayed implant placement, depending on the available residual alveolar ridge height that necessary for implant primary stability.
The new compartment created between the floor of maxillary sinus and the elevated membrane was filled with either autogenous, allografts, xenograft or combination of them to maintain space for new bone formation. The disadvantages of such methods are high costs for grafting material, time consuming and high morbidity, because harvesting of bone grafts is needed.
Detailed description
Recently, a systematic review demonstrated the effectiveness of synthetic bone materials, including biphasic calcium phosphate (BCP), as substitutes for autogenous bone. BCP consists of hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP). In contrast with stable HA, β-TCP is highly resorptive and is replaced by newly formed bone; therefore, the resorption rate of BCP could be influenced by the ratio of HA and β-TCP.
platelet-rich fibrin (PRF) was recently introduced as additional or replacement materials in bone augmentation procedures. The use of biologic mediators with osteoinductive properties has been considered to reduce the time interval and accelerate the formation of new bone. The strengths of PRF in reducing tissue inflammation, promoting the vascularization of bone tissue, accelerating new bone formation, and improving scaffold mechanics have been reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group I, patients undergo sinus lifting using bone substitute BCP alone. -Group II, patients who undergo sinus lifting using BCP with I-PRF.
| Arm | Type | Receives |
|---|---|---|
| Group 1 BCP alone | Active comparator | Procedure: Lateral sinus floor augmentation, Drug: Biphasic Calcium PhosphateLateral bone augmentation with biphasic calcium phosphate BCP bone substitute application |
| Group 2 BCP with I-PRF | Active comparator | Procedure: Lateral sinus floor augmentation, Drug: Biphasic Calcium Phosphate, Procedure: Injectable platlets rich fibrinLateral bone augmentation with biphasic calcium phosphate BCP bone substitute application with addition of injectable platlet rich fibrin I-PRF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Residual bone crest height < 5 mm and width≥6 mm in the planned implant site.
- Healed bone crest (at least 6 months elapsed from tooth loss/extraction);
Key exclusion criteria (1 listed)
- Absolute medical contraindications to implant surgery such as uncontrolled diabetes mellitus, blood platelet disorders, serious osseous disorders, and cardiac arrhythmia; history of bone grafting in the posterior maxilla, immunocompromised patients, taking corticosteroids, taking aspirin before the procedure, positive history of chemotherapy and radiotherapy, and maxillary sinus pathologies
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 sinus floor augmentationmaxillary sinus floor augmentation by lateral approach | Procedure or surgery | Group 1 BCP alone, Group 2 BCP with I-PRF |
| Biphasic Calcium Phosphateappliaction of BCP bone substitute | Drug | Group 1 BCP alone, Group 2 BCP with I-PRF |
| Injectable platlets rich fibrincentrifuge 10 ml of patient blood to get I-PRF that applied to the bone substitute | Procedure or surgery | Group 2 BCP with I-PRF |
Primary outcome
Vertical bone gain BG
Time frame: 6 months
Vertical bone gain (BG) 6 months after sinus augmentation in both height and density aspects by cone beam CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lateral sinus floor augmentation, Biphasic Calcium Phosphate and Injectable platlets rich fibrin in people with Maxillary Sinus Disease, run by Assiut 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 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. 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.
What does this 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.
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 Alzahraa Alghriany, Lecturer (+201203770058, alghriany@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical bone gain BG (time frame: 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 31 Jan 2024.