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

NCT06673355 | Active Not Recruiting

• 1 other identifier: RECO6U/2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Mandible

Keywords

all on 4 full arch restorations in the mandible

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• occlusal surface wear analysis

  12 months

Study Arms (2)

patients will receive frameworks made of high-performance polymer

EXPERIMENTAL

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 porcelain fused to titanium

ACTIVE COMPARATOR

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

Interventions

dental implant prosthesis OTHER

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

patients will receive frameworks made of high-performance polymer; patients will receive frameworks made of porcelain fused to titanium

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

Misr University for Science and Technology

Giza, Giza Governorate, 12573, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - Lecturer of Removable Prosthodontics

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 4, 2024
• Study Start: July 8, 2024
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: starting 6 months after publication
• Access Criteria: practitioners interested in the same field of research

Locations

EG (1)