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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06673355
Acronym
CSDSMDA
Enrollment
32
Registered
2024-11-04
Start date
2024-07-08
Completion date
2025-08-08
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edentulous Mandible

Keywords

all on 4 full arch restorations in the mandible

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.

Interventions

OTHERdental implant prosthesis

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

Sponsors

Misr University for Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
MALE
Age
25 Years to 55 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
bone height changes around the implants12 monthsbone 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.

Secondary

MeasureTime frameDescription
occlusal surface wear analysis12 monthsocclusal 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026