Maxillary SinusNCT06846632
Graftless Technique in Open Maxillary Sinus Lifting Using PEEK Versus Ti -Meshwork
A study testing PEEK and titanium meshwork in people with Maxillary Sinus, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to assess the amount of bone formation with PEEK (intervention group) in comparison with Titanium Meshwork (control group) in maxillary sinus lifting using CBCT and assessment of the biocompatibility of the Meshwork and PEEK with the schniederian membrane integrity. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus
- What is being tested?
- PEEK and titanium meshwork
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 3 May 2024to 3 Nov 2024
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height of 3 to 6 mm.
- Patient age ranges from 25 to 50 years.
- 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 complains from maxillary sinusitis
- Patients are free from T.M.J disorders, abnormal oral habits such as bruxism.
- Patient with good oral hygiene.
Who cannot join
- • Untreated gingivitis, periodontitis.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Insufficient oral hygiene and motivation.
- Pregnant or nursing.
- Bone pathology.
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- Patient with blood disease.
- Patient with any systematic disease that may affect normal healing.
- Active infection or severe inflammation in the area intended for implant placement.
- Treated or under treatment with intravenous amino-bisphosphonates.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Graftless Technique in Open Maxillary Sinus Lifting Using Poly-Ether-Ether-Ketone Versus Titanium Meshwork for Evaluation of Bone Quantity: Randomized Clinical Trials
The aim of the study is to assess the amount of bone formation with PEEK (intervention group) in comparison with Titanium Meshwork (control group) in maxillary sinus lifting using CBCT and assessment of the biocompatibility of the Meshwork and PEEK with the schniederian membrane integrity.
Read the detailed description
All patients involved in this study will be divided into two equal groups, each group will be; (Tested group): PEEK after maxillary sinus lifts (Caldwell luc approach). (Control group): Titanium meshwork after maxillary sinus lifts (Caldwell luc approach).
Clinical evaluation:
A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations.
A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest and take a primary measurement for the residual bone height of maxillary sinus.
CBCT will be taken in order to design the custom-made PEEK model and its guide of external window before the milling.
Intra operative procedures for two groups:
The operation was carried out with the patient under local anesthesia (2% Lido HCl with 1:100,000 epinephrine). The perioral areas were aseptically prepared. A crestal incision was made on the midline of the gingiva attached to the edentulous ridge. The flap was elevated carefully and extended labially to expose the bone. A mesial and distal vertical releasing incision will be made as needed. The mucosal flap was denuded subperiosteally to fully expose the sharp and thin alveolar ridge and the lateral wall of the maxillary sinus. Extreme care was taken to radically elevate the sinus membrane from the lateral access window opened by using an electric-motor drill with appropriate water cooling. The floor, lateral wall, medial and posterior wall of the sinus membrane were meticulously detached and pushed upward for the placement of PEEK in intervention group and titanium meshwork in control group.
- Follow up: Patients will be evaluated after 3 days and weekly for the first month and then after 6 months Radiographic assessment will be achieved by CBCT scan 6 months postoperatively to calculate the amount of vertical bone gain.
- Conditions
- Maxillary Sinus
- Being tested
- PEEK, titanium meshwork
- Keywords
- maxillary sinus lifting , PEEK , titanium meshwork
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEKDevice
Also called poly ether ether ketone
placement of PEEK after maxillary sinus lifting
titanium meshworkDevice
placement of titanium meshwork after maxillary sinus lifting
| Study group | Role | What they receive |
|---|---|---|
| placement of titanium meshwork after maxillary sinus lifting | Experimental | placement of titanium meshwork after maxillary sinus lifting Receives: Device: titanium meshwork |
| placement of PEEK after maxillary sinus lifting | Experimental | placement of PEEK after maxillary sinus lifting Receives: Device: PEEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone quantity
assessment of bone quantity using CBCT
Measured: at 6 months of maxillary sinus lifting
Secondary outcomes (1)
Compatibility with Schneiderian membrane
assessment of the biocompatibility with Schneiderian membrane
Measured: at 6 months of maxillary sinus lifting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start3 May 2024
- Primary completion3 Oct 2024
- Study completion3 Nov 2024
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
- Single blind
- Who is masked
- Participant
- 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
- NCT06846632
- Sponsor's protocol ID
- 33-6-24
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Graftless Technique in Open Maxillary Sinus Lifting Using Poly-Ether-Ether-Ketone Versus Titanium Meshwork for Evaluation of Bone Quantity: Randomized Clinical Trials
- ClinicalTrials.gov ID
- NCT06846632
- Acronym / sponsor ID
- 33-6-24
- Conditions
- Maxillary Sinus
- Keywords
- maxillary sinus lifting , PEEK , titanium meshwork
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 3 Nov 2024 (actual)
- First posted
- 26 Feb 2025 (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.
The aim of the study is to assess the amount of bone formation with PEEK (intervention group) in comparison with Titanium Meshwork (control group) in maxillary sinus lifting using CBCT and assessment of the biocompatibility of the Meshwork and PEEK with the schniederian membrane integrity.
Detailed description
All patients involved in this study will be divided into two equal groups, each group will be; (Tested group): PEEK after maxillary sinus lifts (Caldwell luc approach). (Control group): Titanium meshwork after maxillary sinus lifts (Caldwell luc approach).
Clinical evaluation:
A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations.
A preoperative digital panoramic radiograph with 1:1 magnification was taken for each patient as a primary survey in order to exclude the presence of any lesion at the area of interest and take a primary measurement for the residual bone height of maxillary sinus.
CBCT will be taken in order to design the custom-made PEEK model and its guide of external window before the milling.
Intra operative procedures for two groups:
The operation was carried out with the patient under local anesthesia (2% Lido HCl with 1:100,000 epinephrine). The perioral areas were aseptically prepared. A crestal incision was made on the midline of the gingiva attached to the edentulous ridge. The flap was elevated carefully and extended labially to expose the bone. A mesial and distal vertical releasing incision will be made as needed. The mucosal flap was denuded subperiosteally to fully expose the sharp and thin alveolar ridge and the lateral wall of the maxillary sinus. Extreme care was taken to radically elevate the sinus membrane from the lateral access window opened by using an electric-motor drill with appropriate water cooling. The floor, lateral wall, medial and posterior wall of the sinus membrane were meticulously detached and pushed upward for the placement of PEEK in intervention group and titanium meshwork in control group.
- Follow up: Patients will be evaluated after 3 days and weekly for the first month and then after 6 months Radiographic assessment will be achieved by CBCT scan 6 months postoperatively to calculate the amount of vertical bone gain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placement of titanium meshwork after maxillary sinus lifting | Experimental | Device: titanium meshworkplacement of titanium meshwork after maxillary sinus lifting |
| placement of PEEK after maxillary sinus lifting | Experimental | Device: PEEKplacement of PEEK after maxillary sinus lifting |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height of 3 to 6 mm.
Key exclusion criteria (10 listed)
- • Untreated gingivitis, periodontitis.
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 |
|---|---|---|
| PEEKAlso: poly ether ether ketoneplacement of PEEK after maxillary sinus lifting | Device | placement of PEEK after maxillary sinus lifting |
| titanium meshworkplacement of titanium meshwork after maxillary sinus lifting | Device | placement of titanium meshwork after maxillary sinus lifting |
Primary outcome
Bone quantity
Time frame: at 6 months of maxillary sinus lifting
assessment of bone quantity using CBCT
1 secondary outcome
Compatibility with Schneiderian membrane
Time frame: at 6 months of maxillary sinus lifting
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 26 Feb 2025.
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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 and titanium meshwork 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 7 inclusion and 10 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 26 Feb 2025. 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: at 6 months of maxillary sinus lifting). 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 26 Feb 2025.