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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Edentulous Mandible
• Intervention / Treatment: Other: dental implant prosthesis

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12573
    • Misr University for Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

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
Experimental: 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.	Other: dental implant prosthesis; patients will receive frameworks made of high-performance polymer filled with nano zirconia and carbon
Active Comparator: 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	Other: dental implant prosthesis; patients will receive frameworks made of high-performance polymer filled with nano zirconia and carbon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone height changes around the implants	bone height changes around the implants will be assessed using CBCT. this will be acquired at the time of insertion, after 6 months and after 12 months. bone height changes will be measured at the buccal, mesial, distal and lingual surfaces around each implant.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
occlusal surface wear analysis	occlusal surface wear analysis will be performed by taking intraoral scans and saving the scan (STL) files to be imported into a specific software that is used to compare and measure the deviations between the reference file and the new files. the scans will be taken at the time of framework insertion, after 6 months and after 12 months post-insertion.	12 months

Collaborators and Investigators

• Sponsor: Misr University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Estimated): August 8, 2025
• Study Completion (Estimated): August 8, 2025

Study Registration Dates

• First Submitted: November 1, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Estimated): November 4, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: all on 4 full arch restorations in the mandible
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: RECO6U/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD collected throughout the trial, only IPD used in the results publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: practitioners interested in the same field of research
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

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