Sinus Lift AugmentationNCT06626776
The Use of Extended Platelet Rich Fibrin in Lateral Sinus Augmentation
A study testing lateral sinus lift with using allograft and collagen membrane and lateral sinus lift with using exteneded platelet rich fibrin in people with Sinus Lift Augmentation, run by Mansoura University at 1 site in Egypt.
Trial summary
thirty implants will be inserted in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sinus Lift Augmentation
- What is being tested?
- lateral sinus lift with using allograft and collagen membrane and lateral sinus lift with using exteneded platelet rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Oct 2025
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patent ostium of maxillary sinus.
- Patient with missing one or more posterior maxillary teeth.
- Residual bone height of 3-6 mm, measured from the crest of alveolar ridge to the floor of the maxillary sinus at the planned implant site.
- A ridge width at the site of implantation of <5mm.
- Platelets of normal range.
- Good oral hygiene.
Show all 9Show fewer
- Patients in the age frame between 20 years and 60 years old.
- No gender preface in selection of the patients.
- A minimum crown height space of 8 mm.
Who cannot join
- Active sinusitis, cyst, tumors or root tips at the planned surgical site.
- Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
- Heavy smoking and alcoholism.
- Parafunctional habits such as bruxism and clenching.
- Signs of acute infection or pus discharge.
- Disturbed occlusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extended Platelet Rich Fibrin in Lateral Maxillary Sinus Lifting With Simultaneous Implant Placement.
thirty implants will be inserted in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization. The patients will be selected from those attending the outpatient clinic of the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
- Clinical Evaluation
- Implant stability
- Radiographic Evaluation Vertical bone gain (VBG)
- Conditions
- Sinus Lift Augmentation
- Being tested
- lateral sinus lift with using allograft and collagen membrane, lateral sinus lift with using exteneded platelet rich fibrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lateral sinus lift with using allograft and collagen membraneProcedure or surgery
sinus floor elevation with placing allograft and collagen membrane
lateral sinus lift with using exteneded platelet rich fibrinProcedure or surgery
sinus floor elevation with placing eprf
| Study group | Role | What they receive |
|---|---|---|
| lateral sinus lift with bone augmenation | Experimental | Not described Receives: Procedure: lateral sinus lift with using allograft and collagen membrane |
| lateral sinus lift with extended platelet rich fibrin | Experimental | Not described Receives: Procedure: lateral sinus lift with using exteneded platelet rich fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
the stability of the implants will be evaluated by RFA with the Osstell Mentor device.
Measured: 9 months
Vertical bone height
vertical bone height will be measured as the distance from the alveolar crest to the new sinus floor at the middle of the implant
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 posted4 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Lift AugmentationStudies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626776
- Sponsor's protocol ID
- A0102024OS
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Platelet Rich Fibrin in Lateral Maxillary Sinus Lifting With Simultaneous Implant Placement.
- ClinicalTrials.gov ID
- NCT06626776
- Acronym / sponsor ID
- A0102024OS
- Conditions
- Sinus Lift Augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 4 Oct 2024 (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.
thirty implants will be inserted in patients seeking implantation of their lost posterior maxillary teeth (premolar and molars) with limited bone height below the floor of the maxillary sinus, secondary to sinus pneumatization. The patients will be selected from those attending the outpatient clinic of the Oral \& Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University.
- Clinical Evaluation
- Implant stability
- Radiographic Evaluation Vertical bone gain (VBG)
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 |
|---|---|---|
| lateral sinus lift with bone augmenation | Experimental | Procedure: lateral sinus lift with using allograft and collagen membrane |
| lateral sinus lift with extended platelet rich fibrin | Experimental | Procedure: lateral sinus lift with using exteneded platelet rich fibrin |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patent ostium of maxillary sinus.
- Patient with missing one or more posterior maxillary teeth.
- Residual bone height of 3-6 mm, measured from the crest of alveolar ridge to the floor of the maxillary sinus at the planned implant site.
- A ridge width at the site of implantation of <5mm.
- Platelets of normal range.
Key exclusion criteria (6 listed)
- Active sinusitis, cyst, tumors or root tips at the planned surgical site.
- Patients with systemic diseases that contra-indicate the surgical procedure such as uncontrolled diabetes mellitus, bleeding disorders, serious osseous disorders, and mental disorders.
- Heavy smoking and alcoholism.
- Parafunctional habits such as bruxism and clenching.
- Signs of acute infection or pus discharge.
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 lift with using allograft and collagen membranesinus floor elevation with placing allograft and collagen membrane | Procedure or surgery | lateral sinus lift with bone augmenation |
| lateral sinus lift with using exteneded platelet rich fibrinsinus floor elevation with placing eprf | Procedure or surgery | lateral sinus lift with extended platelet rich fibrin |
Primary outcome
implant stability
Time frame: 9 months
the stability of the implants will be evaluated by RFA with the Osstell Mentor device.
Vertical bone height
Time frame: 6 months
vertical bone height will be measured as the distance from the alveolar crest to the new sinus floor at the middle of the implant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
Related trials for Sinus Lift Augmentation
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Not yet recruitingEarly Phase 1
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation With Leukocyte Platelet Rich Fibrin
Partially Edentulous Maxilla
Active, not recruiting
Endoscopic-Assisted Versus Conventional Crestal Sinus Lift
Bone Defects
Not yet recruitingObservational study
Outcomes of Different Bone Graft Combinations for Maxillary Sinus Augmentation Procedure
Bone Grafting, Sinus Lifting
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lateral sinus lift with using allograft and collagen membrane and lateral sinus lift with using exteneded platelet rich fibrin in people with Sinus Lift Augmentation, run by Mansoura University at 1 site in Egypt.
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 9 inclusion and 6 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 4 Oct 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ammar samman (+201558990325, dr.3mmar@std.mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
implant stability (time frame: 9 months). The study lists 2 primary outcomes in all. 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 4 Oct 2024.