ClinicalTrials.gg
CompletedNCT06846632Updated Feb 26, 2025

Graftless Technique in Open Maxillary Sinus Lifting Using PEEK Versus Ti -Meshwork

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

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled May 2024, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
25 Years to 50 Years
Sex
All
01

Study 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 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.
02

Conditions studied

  • Maxillary Sinus

Keywords

  • maxillary sinus lifting , PEEK , titanium meshwork
03

In context

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    • 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.

Exclusion criteria

Exclusion Criteria:

    • 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.
      • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    placement of titanium meshwork after maxillary sinus lifting

    placement of titanium meshwork after maxillary sinus lifting

    Device: titanium meshwork

  • Experimental
    placement of PEEK after maxillary sinus lifting

    placement of PEEK after maxillary sinus lifting

    Device: PEEK

Interventions

  • DevicePEEK

    placement of PEEK after maxillary sinus lifting

    Also known as: poly ether ether ketone

  • Devicetitanium meshwork

    placement of titanium meshwork after maxillary sinus lifting

06

What researchers measure

Primary outcomes

  1. Bone quantity

    assessment of bone quantity using CBCT

    Time frame: at 6 months of maxillary sinus lifting

Secondary outcomes

  1. Compatibility with Schneiderian membrane

    assessment of the biocompatibility with Schneiderian membrane

    Time frame: at 6 months of maxillary sinus lifting

07

Study locations

1 site
  • Faculty of Dentistry Cairo University
    Cairo, 14444, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06846632
Lead sponsor
Cairo University
Responsible party
mohamed gamal hammad (MSc degree of oral and maxillofacial surgery, Cairo University) — Principal investigator
First posted
Feb 26, 2025
Start date
May 3, 2024
Primary completion
Oct 3, 2024
Completion
Nov 3, 2024
Last update
Feb 26, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion