Maxillary DiseasesNCT04160780
Lateral Sinus Augmentation Using L-PRF as Sole Graft Material
A study testing L-PRF, L-PRF mixed with xenograft and xenograft in people with Maxillary Diseases, run by British University In Egypt.
Trial summary
Severe maxillary atrophy occurs after extraction of teeth in poster maxilla due to dimensional changes occur after removal; besides, sinus membrane pneumatization causes alveolar bone resorption, different classification for remaining alveolar bone in the posterior maxilla were done. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Diseases
- What is being tested?
- L-PRF, L-PRF mixed with xenograft and xenograft
- Type of treatment
- 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
- 26 Mar 2016to 1 Apr 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult patients.
- Both sex, males and females.
- Age from 24 - 49 years old.
- All patients were free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
- Extraction done at posterior maxilla involved with the maxillary sinus.
- Remaining alveolar bone ≤ 5mm vertically and ≥ 4mm horizontally and from 1.5 mm to 3.5 mm vertically.
- Gingival biotype 1-2mm thickness.
- Patient has no previous surgery in Maxillary antrum.
Who cannot join
- Smokers.
- Pregnant and breast-feeding females.
- Mentally retarded Patients.
- Presence of hematologic disease.
- Previous radiation, chemotherapy, or immunosuppressive treatments.
- Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
- Patient with history of chronic sinus pathosis
- Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure.
About this study
Official title: Lateral Sinus Augmentation Using L-PRF and Xenograft: Radiographic and Histomorphometry Analysis.
Severe maxillary atrophy occurs after extraction of teeth in poster maxilla due to dimensional changes occur after removal; besides, sinus membrane pneumatization causes alveolar bone resorption, different classification for remaining alveolar bone in the posterior maxilla were done. In this study, the ABC sinus classification was followed in case selection. A sinus augmentation is done with several techniques. Sinus membrane elevation is done with two different approaches, either the crestal approach or lateral window approach.
Using biofiller material for sinus membrane elevation has been tried by many researchers, using a bone graft, platelet concentrates preparation, collagen membranes, tenting screws, or with implant tenting.
Read more
In this study, sinus augmentation was performed using a lateral window approach using L-PRF as sole biofiller material in one group, xenograft as only biofiller material in the second group and mixed xenograft with L-PRF in the third group. Histomorphometric analysis was done from the core biopsy after three months of augmentation, and implant placement was done.
After three months, prosthetic parts were placed. The results of this study show that the augmentation of the sinus using L-PRF mixed with bone graft is showing the best results followed by L-PRF only, and the least was xenograft.
From this point of discussion, it can be considered that using L-PRF as sole biofiller material in sinus augmentation.
- Conditions
- Maxillary Diseases
- Being tested
- L-PRF, L-PRF mixed with xenograft, xenograft
- Medical subject headings
- Maxillary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-PRFProcedure or surgery
sinus augmentation using L-PRf as sole graft material
L-PRF mixed with xenograftProcedure or surgery
sinus augmentation using L-PRF mixed with xenograft as sole graft material
xenograftProcedure or surgery
sinus augmentation using xenograft as sole graft material
| Study group | Role | What they receive |
|---|---|---|
| L-PRF as sole graft material | Experimental | lateral sinus augmentation using L-PRF as sole graft material Receives: Procedure: L-PRF |
| xenograft as sole graft material | Experimental | lateral sinus augmentation using xenograft as sole graft material Receives: Procedure: xenograft |
| Xenograft mixed with L-PRF as graft material | Experimental | lateral sinus augmentation using L-PRF mixed with xenograft as graft material Receives: Procedure: L-PRF mixed with xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
histomorphometric analysis
After three months from sinus augmentation, a second surgery will be done for implant placement; during this procedure, a bone core biopsy will be harvested. The biopsy will be stained with mason stain for histomorphometric analysis. The aim is to measure the newly formed bone for three months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start26 Mar 2016
- Primary completion1 Mar 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary DiseasesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alhassan Diab, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160780
- Sponsor's protocol ID
- 280986
- Status last verified
- Dec 2019
- First submitted
- 8 Sep 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Sinus Augmentation Using L-PRF and Xenograft: Radiographic and Histomorphometry Analysis.
- ClinicalTrials.gov ID
- NCT04160780
- Acronym / sponsor ID
- 280986
- Conditions
- Maxillary Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 26 Mar 2016 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 13 Nov 2019 (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.
Severe maxillary atrophy occurs after extraction of teeth in poster maxilla due to dimensional changes occur after removal; besides, sinus membrane pneumatization causes alveolar bone resorption, different classification for remaining alveolar bone in the posterior maxilla were done. In this study, the ABC sinus classification was followed in case selection. A sinus augmentation is done with several techniques. Sinus membrane elevation is done with two different approaches, either the crestal approach or lateral window approach.
Using biofiller material for sinus membrane elevation has been tried by many researchers, using a bone graft, platelet concentrates preparation, collagen membranes, tenting screws, or with implant tenting.
In this study, sinus augmentation was performed using a lateral window approach using L-PRF as sole biofiller material in one group, xenograft as only biofiller material in the second group and mixed xenograft with L-PRF in the third group. Histomorphometric analysis was done from the core biopsy after three months of augmentation, and implant placement was done.
After three months, prosthetic parts were placed. The results of this study show that the augmentation of the sinus using L-PRF mixed with bone graft is showing the best results followed by L-PRF only, and the least was xenograft.
From this point of discussion, it can be considered that using L-PRF as sole biofiller material in sinus augmentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L-PRF as sole graft material | Experimental | Procedure: L-PRFlateral sinus augmentation using L-PRF as sole graft material |
| xenograft as sole graft material | Experimental | Procedure: xenograftlateral sinus augmentation using xenograft as sole graft material |
| Xenograft mixed with L-PRF as graft material | Experimental | Procedure: L-PRF mixed with xenograftlateral sinus augmentation using L-PRF mixed with xenograft as graft material |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy adult patients.
- Both sex, males and females.
- Age from 24 - 49 years old.
- All patients were free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
- Extraction done at posterior maxilla involved with the maxillary sinus.
Key exclusion criteria (8 listed)
- Smokers.
- Pregnant and breast-feeding females.
- Mentally retarded Patients.
- Presence of hematologic disease.
- Previous radiation, chemotherapy, or immunosuppressive treatments.
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 |
|---|---|---|
| L-PRFsinus augmentation using L-PRf as sole graft material | Procedure or surgery | L-PRF as sole graft material |
| L-PRF mixed with xenograftsinus augmentation using L-PRF mixed with xenograft as sole graft material | Procedure or surgery | Xenograft mixed with L-PRF as graft material |
| xenograftsinus augmentation using xenograft as sole graft material | Procedure or surgery | xenograft as sole graft material |
Primary outcome
histomorphometric analysis
Time frame: 3 months
After three months from sinus augmentation, a second surgery will be done for implant placement; during this procedure, a bone core biopsy will be harvested. The biopsy will be stained with mason stain for histomorphometric analysis. The aim is to measure the newly formed bone for three 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 5 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing L-PRF, L-PRF mixed with xenograft and xenograft in people with Maxillary Diseases, run by British University 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 8 inclusion and 8 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 5 Dec 2019. 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.
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?
histomorphometric analysis (time frame: 3 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 5 Dec 2019.