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

Not Applicable

Active, not recruiting

• Conditions: Ridge Augmentaton and Dental Implants; Bone Loss, Alveolar

• Registration Number: NCT06933030
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2025-03-06
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-10
• Last Update Submitted: 2025-04-10
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-08-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical evaluation	6 months	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.

Secondary Outcome Measures

Name	Time	Method
radiographic bone volume	6,12 months	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.
histologically	6 months	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.

Trial Locations

Locations (1)

Tanta university; 🇪🇬 Tanta, Egypt