An interventional study of PEEK and titanium meshwork in Maxillary Sinus, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Posterior edentulous ridges with pneumatized maxillary sinus and remaining bone height of 3 to 6 mm.
Exclusion Criteria:
Untreated gingivitis, periodontitis.
placement of titanium meshwork after maxillary sinus lifting
Device: titanium meshwork
placement of PEEK after maxillary sinus lifting
Device: PEEK
placement of PEEK after maxillary sinus lifting
Also known as: poly ether ether ketone
placement of titanium meshwork after maxillary sinus lifting
Bone quantity
assessment of bone quantity using CBCT
Time frame: at 6 months of maxillary sinus lifting
Compatibility with Schneiderian membrane
assessment of the biocompatibility with Schneiderian membrane
Time frame: at 6 months of maxillary sinus lifting
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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