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

NCT06933030 | Active Not Recruiting

• 1 other identifier: OMPDR7-242235
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ridge Augmentaton and Dental Implants; Bone Loss, Alveolar

Keywords

ridge augmentation; dental implant; titanium mesh; zirconium mesh

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• radiographic bone volume

  6,12 months

• histologically

  6 months

Study Arms (2)

Group I (controlled group): -

OTHER

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.

Group II (tested group):

EXPERIMENTAL

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.

Interventions

titanium mesh with bone graft with delayed implant placement. DEVICE

titanium mesh with bone graft with delayed implant placement.

Group I (controlled group): -

zirconium mesh with bone graft with delayed implant placement. DEVICE

zirconium mesh with bone graft with delayed implant placement.

Group II (tested group):

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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)
• Adequate zone of keratinized gingiva at minimum 3mms.
• Patient with sufficient inter-arch space for future dental rehabilitation.
• Subjects who are not on any medication known to interfere with periodontal tissue health or healing within 6 months of the study.

You may not qualify if:

• 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.
• Patients with deleterious habits like the use of tobacco chewing or smoking ones.
• History of previous periodontal surgical treatment of the involved sites.
• Presence of malocclusion and pathologic movement of teeth in involved sites.
• Patient not willing to give consent for the study and poor plaque control.(57)
• Pregnant or nursing mothers.
• Patients with acute odontogenic infection.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university

Tanta, Egypt

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Bone Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Surgical Procedures, Operative; Transplantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT LECTURER

Model Details: Group I (controlled group): \- Ten sites of anterior maxillary ridge atrophy will be treated by titanium mesh with bone graft with delayed implant placement. Group II (tested group): \- Ten sites anterior maxillary ridge atrophy will be treated by zirconium mesh with bone graft with delayed implant placement.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 17, 2025
• Study Start: September 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

EG (1)