Titanium Mesh vs Customized PEEK Mesh for Horizontal Maxillary Ridge Augmentation: A Randomized Clinical Trial

NCT07002931 | Completed

• 1 other identifier: IRB00012490
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Reconstruction of the deficient maxillary ridge in three dimensions is crucial for the successful placement of implants. Prebent titanium meshes are an established modality for GBR, while patient-specific PEEK meshes have recently emerged with some possible advantages over the former. This study compared the effectiveness of these two modalities for bone augmentation. Materials and Methods: 14 patients with 28 augmented sites in the maxillary ridges of primarily horizontal bone deficiencies, often associated with minor vertical components, were randomly assigned to two groups. The control group (n=7) was augmented with a prebent titanium mesh, while the study group (n=7) was augmented with a customized milled PEEK mesh. Both were grafted with a mixture of autogenous bone and xenograft. The primary outcome was horizontal bone gain. Secondary outcomes included vertical bone gain, gained bone volume, and graft resorption. These parameters were assessed by CBCT preoperatively, immediately postoperatively, and at 6 months before implant placement.

Conditions

Alveolar Bone Atrophy

Keywords

alveolar bone augmentation; horizontal bone augmentation

Outcome Measures

Primary Outcomes (1)

• Horizontal bone gain (mm)

  Horizontal bone gain will be assessed using CBCT scans performed preoperatively, immediately postoperatively, and 6 months postoperatively. Measurements will be taken at standardized reference points perpendicular to the alveolar ridge.

  6 months

Secondary Outcomes (3)

• Vertical bone gain (mm)

  6 months

• Gained bone volume (mm³)

  Immediate postoperative

• Graft resorption volume (mm³)

  6 months

Study Arms (2)

Prebent titanium mesh

ACTIVE COMPARATOR

Ridge augmentation was performed using a prebent titanium mesh adapted on a stereolithographic model. The graft consisted of a mixture of autogenous bone and xenograft in a 60:40 ratio. The mesh was fixed using titanium screws to maintain space for bone regeneration.

Procedure: Prebent titanium mesh augmentation

Customized PEEK mesh

EXPERIMENTAL

Ridge augmentation was performed using a patient-specific CAD/CAM milled PEEK mesh. The graft consisted of a mixture of autogenous bone and xenograft in a 70:30 ratio. The mesh was fixed using titanium screws to maintain space for bone regeneration.

Procedure: Customized PEEK mesh augmentation

Interventions

Prebent titanium mesh augmentation PROCEDURE

Guided bone regeneration using a prebent titanium mesh combined with a mixture of autogenous bone and xenograft in a 60:40 ratio.

Prebent titanium mesh

Customized PEEK mesh augmentation PROCEDURE

Guided bone regeneration using a customized CAD/CAM PEEK mesh combined with a mixture of autogenous bone and xenograft in a 70:30 ratio.

Customized PEEK mesh

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Basma Alsheikh: lead

Study Sites (1)

Faculty of dentistry, British university of egypt

Cairo, Cairo Governorate, 11837, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment was performed by a blinded examiner during CBCT analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 4, 2025
• Study Start: July 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

EG (1)