Maxillary SinusNCT06521853
Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation
A study testing PEEK With Autogenous Bone Graft and PEEK With Xenograft in people with Maxillary Sinus, run by Cairo University at 1 site in Egypt.
Trial summary
Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus
- What is being tested?
- PEEK With Autogenous Bone Graft and PEEK With Xenograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 31 Dec 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- posterior edentulous ridge less than 4mm in bone height
Who cannot join
- insufficient oral hygiene and motivation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation: Clinical, Radiographic and Histomorphometric Analysis. Randomized Clinical Trials.
Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation
Read the detailed description
Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation: clinical, radiographic and histomorphometric analysis .
- Conditions
- Maxillary Sinus
- Being tested
- PEEK With Autogenous Bone Graft, PEEK With Xenograft
- Keywords
- maxillary sinus augmentation ; bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK With Autogenous Bone GraftOther
placement of PEEK With Autogenous Bone Graft
PEEK With XenograftOther
placement of PEEK With xenograft
| Study group | Role | What they receive |
|---|---|---|
| PEEK With Autogenous Bone Graft | Experimental | maxillary sinus elevation using PEEK device and placement of autogenous bone graft Receives: Other: PEEK With Autogenous Bone Graft |
| PEEK With Xenograft | Experimental | maxillary sinus elevation using PEEK device and placement of xenograft Receives: Other: PEEK With Xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone height
using CBCT in mm
Measured: after 6 months
Secondary outcomes (1)
bone quality
core biopsy (Histomorphometric evaluation)
Measured: after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Jun 2023
- Primary completion1 Jul 2023
- Study completion31 Dec 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 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
- NCT06521853
- Sponsor's protocol ID
- 33-6-23
- Status last verified
- Nov 2024
- First submitted
- 17 Apr 2024
- Last updated
- 19 Nov 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 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation: Clinical, Radiographic and Histomorphometric Analysis. Randomized Clinical Trials.
- ClinicalTrials.gov ID
- NCT06521853
- Acronym / sponsor ID
- 33-6-23
- Conditions
- Maxillary Sinus
- Keywords
- maxillary sinus augmentation ; bone graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Jul 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 PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation
Detailed description
Comparison Between PEEK With Autogenous Bone Graft and PEEK With Xenograft in Maxillary Sinus Augmentation: clinical, radiographic and histomorphometric analysis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEEK With Autogenous Bone Graft | Experimental | Other: PEEK With Autogenous Bone Graftmaxillary sinus elevation using PEEK device and placement of autogenous bone graft |
| PEEK With Xenograft | Experimental | Other: PEEK With Xenograftmaxillary sinus elevation using PEEK device and placement of xenograft |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- posterior edentulous ridge less than 4mm in bone height
Key exclusion criteria (1 listed)
- insufficient oral hygiene and motivation
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 |
|---|---|---|
| PEEK With Autogenous Bone Graftplacement of PEEK With Autogenous Bone Graft | Other | PEEK With Autogenous Bone Graft |
| PEEK With Xenograftplacement of PEEK With xenograft | Other | PEEK With Xenograft |
Primary outcome
bone height
Time frame: after 6 months
using CBCT in mm
1 secondary outcome
bone quality
Time frame: after 6 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 19 Nov 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.
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 PEEK With Autogenous Bone Graft and PEEK With Xenograft 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 1 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: finished, as of the sponsor's last update on 19 Nov 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 height (time frame: after 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 19 Nov 2024.