"Comparative Study of Supra-Structure Materials in Full-Arch Implant Prosthetics: a Randomized Clinical Trial"

NCT ID: NCT06673355

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-08
• Study Completion Date: 2025-08-08

Brief Summary

after the implants' osseointegration period (4 months), digital scans will be taken for the implant positions and the STL files will be stored and sent for the CAD software to design a full arch restoration. Two types will be constructed, Group I patients will receive porcelain fused to titanium frameworks, and Group II will receive a framework made of high-performance polymer filled with nano-zirconia and carbon. After the installation of the frameworks, the bone height changes and the wear of the occlusal surfaces will be monitored at baseline, after 6 months and 12 months post insertion.

Detailed Description

After the implants' osseointegration period of four months, a series of steps will be undertaken to ensure the precise design and implementation of the full-arch restorations.

First, digital scans of the implant positions will be conducted using advanced scanning technology. These scans will accurately capture the spatial orientation and positioning of the implants within the jaw. The resulting STL (Standard Tessellation Language) files, which represent the 3D geometry of the scanned implants, will be securely stored and transmitted to computer-aided design (CAD) software. This software will facilitate the design process for the full-arch restorations.

In this study, two distinct types of full-arch frameworks will be constructed for the participants, who will be divided into two groups based on the material used.

• **Group I** will receive frameworks made of porcelain fused to titanium (P/FtTi). This material is known for its strength, durability, and aesthetic qualities, providing a reliable option for prosthetic restorations.
• **Group II** will receive frameworks crafted from a high-performance polymer enhanced with nano-zirconia and carbon fillers. This innovative material is designed to offer superior mechanical properties, including increased strength and reduced wear while being lightweight and biocompatible.

Once the frameworks are installed in the patient's mouth, the study will focus on monitoring the changes in bone height and the wear of the occlusal surfaces over time. Measurements will be taken at three key intervals: baseline ( time of framework fixation), and then again at six months and twelve months post-insertion.

This monitoring will involve radiographic assessments using CBCT and clinical evaluations to quantify any bone resorption around the implants and to assess the wear patterns of the occlusal surfaces using the intraoral scanner, the STL files of the scans will be superimposed on a software (Geomagic) that is used to measure changes and deviations between the scans. The data collected will provide valuable insights into the long-term performance and stability of the different materials used in the full-arch restorations, thereby contributing to the understanding of their clinical efficacy in implant-supported prosthetics.

Conditions

Edentulous Mandible

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

patients will receive frameworks made of high-performance polymer

patients will receive frameworks made of high-performance polymer filled with nano zirconia and carbon, the framework will be digitally produced by the milling technology using a dental CNC machine. the bone changes and occlusal wear will be assessed at the time of insertion (as a baseline), after 6 months and after 12 months.

Group Type: EXPERIMENTAL

dental implant prosthesis

Intervention Type: OTHER

patients will receive frameworks made of high-performance polymer filled with nano zirconia and carbon

patients will receive frameworks made of porcelain fused to titanium

patients will receive frameworks made of porcelain fused to titanium, the titanium will be produced digitally by 3d printing using the selective laser melting technology. Bone changes and wear of occlusal surfaces will be assessed at time of insertion (baseline, after 6 months and after 12 months

Group Type: ACTIVE_COMPARATOR

dental implant prosthesis

Intervention Type: OTHER

patients will receive frameworks made of high-performance polymer filled with nano zirconia and carbon

Interventions

dental implant prosthesis

patients will receive frameworks made of high-performance polymer filled with nano zirconia and carbon

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• non-smokers
• patients with adequate bone height and width
• patients with good oral hygiene and healthy gingiva

Exclusion Criteria

• smokers
• patients with inadequate bone height and width
• non-compliant patients
• patients with systemic diseases that will affect bone remodelling

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Misr University for Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

HEBA ELSARRIF

Principal Investigator - Lecturer of Removable Prosthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Misr University for Science and Technology

Giza, Giza Governorate, Egypt

Countries

Egypt

Other Identifiers

RECO6U/2024

Identifier Type: -

Identifier Source: org_study_id