Maxillary SinusNCT06376708
Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation
A study testing platelet rich fibrin and Polyether ether ketone in people with Maxillary Sinus, run by Cairo University at 1 site in Egypt.
Trial summary
comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Maxillary Sinus
- What is being tested?
- platelet rich fibrin and Polyether ether ketone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 1 Jul 2023
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height less than 4 mm.
- ASA physical status I and II.
- Patients willing to be a part of the study and ready to give their consent in writing for the same.
- Patient not complain from maxillary sinusitis
- Patient with good oral hygiene.
- Both males as well as females without any active periodontal disease.
- The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
- Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.
Who cannot join
- • General contraindications to implant surgery.
- Untreated gingivitis, periodontitis.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Pregnant or nursing.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- Patients participating in other studies, if the present protocol could not be properly followed.
- Patient who could/would not participate in the follow-up period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation: Histomorphometric and Clinical Analysis: A Randomized Clinical Trial
comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin
Read the detailed description
Histomorphometric and clinical analysis of the bone formed after 6 months after the maxillary sinus elevation using PEEK in the 2 groups : the study group (PEEK with platelet rich fibrin) and the control group (PEEK alone ) .
- Conditions
- Maxillary Sinus
- Being tested
- platelet rich fibrin, Polyether ether ketone
- Keywords
- maxillary sinus elevation and PEEK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich fibrinOther
Also called P.R.F
platelet rich fibrin
Polyether ether ketoneOther
Also called PEEK
Polyether ether ketone
| Study group | Role | What they receive |
|---|---|---|
| PEEK and PRF | Experimental | maxillary sinus elevation using PEEK and platelet rich fibrin Receives: Other: platelet rich fibrin; Other: Polyether ether ketone |
| PEEK alone | Active comparator | maxillary sinus elevation using PEEK alone Receives: Other: Polyether ether ketone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone quantity
using of CBCT
Measured: 6 months postoperatively
Secondary outcomes (1)
Bone quality
Histomorphometic analysis (For Core biopsy)
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Sep 2022
- Primary completion1 Mar 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary SinusStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- use of platelet rich fibrin after maxillary sinus elevation using PEEK
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed gamal hammad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376708
- Sponsor's protocol ID
- 3-3-13
- Status last verified
- Sep 2023
- First submitted
- 28 Mar 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between PEEK With Platelet-rich Fibrin and PEEK Alone in Maxillary Sinus Augmentation: Histomorphometric and Clinical Analysis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06376708
- Acronym / sponsor ID
- 3-3-13
- Conditions
- Maxillary Sinus
- Keywords
- maxillary sinus elevation and PEEK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 19 Apr 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.
comparison between the resulted bone during maxillary sinus elevation by PEEK with and without platelet rich fibrin
Detailed description
Histomorphometric and clinical analysis of the bone formed after 6 months after the maxillary sinus elevation using PEEK in the 2 groups : the study group (PEEK with platelet rich fibrin) and the control group (PEEK alone ) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- use of platelet rich fibrin after maxillary sinus elevation using PEEK
| Arm | Type | Receives |
|---|---|---|
| PEEK and PRF | Experimental | Other: platelet rich fibrin, Other: Polyether ether ketonemaxillary sinus elevation using PEEK and platelet rich fibrin |
| PEEK alone | Active comparator | Other: Polyether ether ketonemaxillary sinus elevation using PEEK alone |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- • Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height less than 4 mm.
Key exclusion criteria (8 listed)
- • General contraindications to implant surgery.
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 |
|---|---|---|
| platelet rich fibrinAlso: P.R.Fplatelet rich fibrin | Other | PEEK and PRF |
| Polyether ether ketoneAlso: PEEKPolyether ether ketone | Other | PEEK alone, PEEK and PRF |
Primary outcome
Bone quantity
Time frame: 6 months postoperatively
using of CBCT
1 secondary outcome
Bone quality
Time frame: 6 months postoperatively
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 19 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Maxillary Sinus
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 recruiting
Buccal Periosteal Inversion Flap vs Buccal Advancement Flap for Acute Oro-Antral Communication Closure
Acute Oroantral Communication
Active, not recruitingPhase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm
Enrolling by invitationPhase 1
Smart Scaffolds, Stronger Smiles Smarter Healing: AI-Boosted Multiphasic Scaffold Design for PDL Regeneration
Regeneration of Alveolar Tissue After Maxillary Sinus Floor Augmentation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich fibrin and Polyether ether ketone in people with Maxillary Sinus, run by Cairo 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 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 19 Apr 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?
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?
Bone quantity (time frame: 6 months postoperatively). 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 19 Apr 2024.