Evaluation of Bone Gain Using Customized 3D Zirconia Barrier Versus Titanium Mesh

NCT06559605 | Recruiting DMC

• 1 other identifier: PER 6-3-1.1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of clinical and radiographical amount of bone gained using customized 3D printed zirconia barrier compared to titanium mesh in combined ridge defect at the esthetic zone.

Conditions

Bone Loss, Alveolar

Keywords

zirconia membrane; titanium membrane; combined bone defect

Outcome Measures

Primary Outcomes (1)

• horizontal bone gain

  Horizontal bone gain will be assessed on CBCT after 6 months of bone augmentation

  6 months

Secondary Outcomes (8)

• Vertical bone gain

  6 months after barrier placement

• Quality of bone

  6 months after barrier placement

• Incidence of membrane exposure

  up to 4 weeks

• Membrane exposure area/percentage

  up to 4 weeks

• Soft tissue thickness

  6 months after barrier placement

Study Arms (2)

zirconia barrier

ACTIVE COMPARATOR

Zirconia will be used as a barrier material because it has interesting features and, if compared to titanium, it induces a better fibroblast response. It also shows less biofilm adhesion and less inflammatory response. From the pre-operative CBCT a 3D model of the alveolar jaw bone will be created. A 0.4-0.5 mm-thick barrier will then be designed. It will be designed to cover the planned bone graft and extended a few millimeters wider than the graft perimeter.

Procedure: zirconia barrier

titanium mesh

PLACEBO COMPARATOR

Titanium mesh in particular, its clinical suitability for GBR procedures is unmatched by other GBR membranes, due to their exceptional volume stability, titanium meshes are indispensable in the management of vertical or large horizontal bone defects. Titanium meshes not only demonstrate high strength and stiffness but also exhibit good plasticity, allowing them to be perfectly adapted to various bone defects through bending and shaping. Due to titanium mesh's stiffness and sharp edges from cutting and bending, mucosal flaps may be adversely stimulated, leading to mucosal rupture and subsequent mesh exposure

Procedure: titanium mesh

Interventions

zirconia barrier PROCEDURE

barrier membrane used for guided bone regeneration and augmentation of ridge defect

Also known as: zirconia membrane

zirconia barrier

titanium mesh PROCEDURE

barrier membrane used for guided bone regeneration

titanium mesh

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 20-70 years.
• Bone width less than 4mm
• Vertical bone height less than 9mm
• Periodontally sound neighboring teeth
• Patients with sound vertical occlusal bite dimension
• Good oral hygiene (full mouth plaque control record \[PCR\] \< 25%,full mouth bleeding on probing (BOP) \< 25% .
• Patients demonstrating understanding and commitment to the post-operative care regime and the study follow up timeline.
• Good general health (including participants with well-controlled systemic disease)

You may not qualify if:

• Pathological lesions (abscess-cyst-acute infection) in the defect site
• Systemic diseases that would interfere with bone metabolism
• Uncontrolled diabetic patients
• Ongoing treatment or a history of recent chemotherapy or radiotherapy
• Poor oral hygiene after hygienic phase (Plaque control record over 30%) or Active periodontal disease

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Hani El Nahass

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Amaal Abdalnassar abdalzeim

CONTACT

01003752752; amaalabdalnassar@gmail.com

Omnia Khaled Tawfik

CONTACT

omnia.tawfik@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Masking of the outcome assessor and patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: August 19, 2024
• Study Start: May 22, 2024
• Primary Completion (Estimated): May 22, 2026
• Study Completion (Estimated): November 22, 2026
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

EG (1)