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CompletedNCT07040124Updated Jun 27, 2025

Assessment of Efficacy of Prebent Titanium Mesh Versus Customized Poly-ether Ether Ketone Mesh for Three Dimensional Augmentation in Deficient Maxillary Ridge. a Randomized Controlled Clinical Trial.

An interventional study of ti mesh and 3d peek mesh in Deficient Alveolar Bone, sponsored by Basma Alsheikh. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by Basma Alsheikh · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 8 months after the study started (first participant enrolled Oct 2020, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

In conclusion, the choice between titanium and PEEK meshes should consider patient-specific factors, clinical requirements, and surgeon expertise. The PEEK mesh, with its patient customized design enabled by CAD/CAM technology, offers significant advantages, including greater gained bone volume and reduced operative time. Its tailored fabrication ensures precise adaptation to the patient's anatomy, effectively maintaining the space required for optimal bone formation. The integration of such advanced technologies in regenerative procedures represents a significant step forward in achieving predictable outcomes and enhancing patient care. However, continued innovation and evaluation are crucial to refine these approaches and expand their applicability in oral rehabilitation

02

Conditions studied

  • Deficient Alveolar Bone

Keywords

  • augmentation,
  • peek
  • titanium mesh
03

In context

Lead sponsor

Basma Alsheikh is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 1. Adult patient of both sexes presenting with partially edentulous maxillary ridge with horizontal bone defect. 2. The horizontal ridge dimension measured 2mm below the alveolar crest should range from 2-5 mm. 3. No local pathosis that may interfere with bone healing. 4. Good oral hygiene. 5. Age between 20-65 years old.

Exclusion criteria

Exclusion Criteria:

  • Patient taking any medication that may interfere with normal bone physiology or impair bone healing. 2. All patients suffering from any systemic disease that may affect bone healing. 3. Heavy smokers (more than 10 cigarette per day) 4. Patients with parafunctional habits such as bruxism and clenching 5. Poor interest and cooperation from the patient. 6. Patients that have undergone any horizontal augmentation procedure at the site of interest
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Active comparator
    prebent titanium mesh

    participants receive alveolar ridge augmentation using pre-bent titanium mesh

    Procedure: ti mesh

  • Active comparator
    3d peek mesh

    participants receive maxillary ridge augmentation using 3d milled peek mesh

    Procedure: 3d peek mesh

Interventions

  • Procedureti mesh

    prebent titamesh on a 3-d virtually augmented model

  • Procedure3d peek mesh

    milled 3d peek mesh

06

What researchers measure

Primary outcomes

  1. horizontal bone gain

    cbct analysis for bone gain

    Time frame: 6 months

07

Study locations

1 site
  • Suez Canal Univresity
    Suez, 111548, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07040124
Lead sponsor
Basma Alsheikh
Responsible party
Basma Alsheikh (assistant lecturer, British University In Egypt) — Sponsor-investigator
First posted
Jun 27, 2025
Start date
Oct 1, 2020
Primary completion
Jan 1, 2025
Completion
Feb 1, 2025
Last update
Jun 27, 2025

Oversight

Data monitoring committee
Yes
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 Jun 2025. You cannot join it, but the record below documents what was studied.

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