Clinical trial NCT06673355: "Comparative Study of Supra-Structure Materials in Full-Arch Implant Prosthetics: a Randomized Clinical Trial"
Official title: Comparative Study of Different Supra-structure Materials in Digitally Designed Full-arch Implant-supported Prosthesis. (Bone Changes and Teeth Wear Analysis) - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Edentulous Mandible
Keywords: all on 4 full arch restorations in the mandible
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 32
Sex: MALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: bone height changes around the implants
timeFrame: 12 months
Secondary outcomes:
measure: occlusal surface wear analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University for Science and Technology
Study officials:
References: