Assessment of Customized 3D Zirconium Versus Titanium Mesh for Anterior Maxillary Ridge Augmentation With Delayed Implant Placement

The aim of the present study is to assess the customized 3D zirconium versus titanium mesh for anterior maxillary ridge augmentation with delayed implant placement.

Study Overview

• Status: Active, not recruiting
• Conditions: Bone Loss, Alveolar; Ridge Augmentaton and Dental Implants
• Intervention / Treatment: Device: titanium mesh with bone graft with delayed implant placement.; Device: zirconium mesh with bone graft with delayed implant placement.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion criteria:

  1. Patients from both genders with the age range of 18-60 years with good systemic health, no contraindication for periodontal surgery and able to maintain good oral hygiene.
  2. Patient with anterior maxillary alveolar ridge deficiency (horizontal, vertical or combined defects) less than 2 mm in width or less than 6 mm in height - measured from the alveolar crest to the basal bone in order to be enrolled in this study. (56)
  3. Adequate zone of keratinized gingiva at minimum 3mms.
  4. Patient with sufficient inter-arch space for future dental rehabilitation.
  5. Subjects who are not on any medication known to interfere with periodontal tissue health or healing within 6 months of the study.

Exclusion Criteria:

Exclusion Criteria:

1. History of systemic diseases (i.e. diabetes, autoimmune dysfunction, prolonged cortisone therapy, or chemotherapy) that would contraindicate periodontal surgical treatment or affect bone turn over.
2. Patients with deleterious habits like the use of tobacco chewing or smoking ones.
3. History of previous periodontal surgical treatment of the involved sites.
4. Presence of malocclusion and pathologic movement of teeth in involved sites.
5. Patient not willing to give consent for the study and poor plaque control.(57)
6. Pregnant or nursing mothers.
7. Patients with acute odontogenic infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group I (controlled group): -; Group I (controlled group): - Ten sites of anterior maxillary ridge atrophy will be treated by titanium mesh with bone graft with delayed implant placement.	Device: titanium mesh with bone graft with delayed implant placement.; titanium mesh with bone graft with delayed implant placement.
Experimental: Group II (tested group): Group II (tested group): - Ten sites anterior maxillary ridge atrophy will be treated by zirconium mesh with bone graft with delayed implant placement.	Device: zirconium mesh with bone graft with delayed implant placement.; zirconium mesh with bone graft with delayed implant placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical evaluation	The patients will be followed up clinically postoperatively every 48-72 hours for the first week then after 2weeks then one month and then after 3 months then after 6 months for preserving: Presence/absence of mesh instability, flap dehiscence, exposed mesh, bone graft loss outside the flap, hematoma or laceration.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic bone volume	A CBCT will be done preoperatively (base line) and after 6 months and finally after 12 months postoperatively to assess dimensions of newly formed bone and its density.	6,12 months
histologically	The bone cores, left inside the trephine burs will be carefully rinsed with a cold 5% glucose solution. The specimens will be fixed in 10% formalin solution at pH 7.2 for a week and dehydrated with a graded series of alcohols. After the pre-infiltration treatment the bone cores will then be completely embedded in 100% resin until the specimens became transparent. Finally, the bone cores will be oriented and polymerized.	6 months

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: dental implant; ridge augmentation; titanium mesh; zirconium mesh
• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: OMPDR7-242235

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No