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.

NCT07040124 | Completed DMC

• 1 other identifier: 1125486
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Deficient Alveolar Bone

Keywords

augmentation,; peek; titanium mesh

Outcome Measures

Primary Outcomes (1)

• horizontal bone gain

  cbct analysis for bone gain

  6 months

Study Arms (2)

prebent titanium mesh

ACTIVE COMPARATOR

participants receive alveolar ridge augmentation using pre-bent titanium mesh

Procedure: ti mesh

3d peek mesh

ACTIVE COMPARATOR

participants receive maxillary ridge augmentation using 3d milled peek mesh

Procedure: 3d peek mesh

Interventions

ti mesh PROCEDURE

prebent titamesh on a 3-d virtually augmented model

prebent titanium mesh

3d peek mesh PROCEDURE

milled 3d peek mesh

3d peek mesh

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Basma Alsheikh: lead

Study Sites (1)

Suez Canal Univresity

Suez, 111548, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: June 27, 2025
• Study Start: October 1, 2020
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)