Viewing Study NCT06558968



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Last Modification Date: 2024-10-26 @ 3:38 PM
Study NCT ID: NCT06558968
Status: RECRUITING
Last Update Posted: None
First Post: 2021-08-30

Brief Title: Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children
Sponsor: None
Organization: None

Study Overview

Official Title: Evaluation of Polyetheretherketone and Monolithic Zirconia as Esthetic Functional Space Maintainers in Children A Randomized Clinical Trial
Status: RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Compare two band and loop space maintainers made from two tooth colored materials Polyetherethherketone PEEK and monolithic Zirconia BruxZir as regards to

Clinical performance of space maintainers in terms of frequency of debonding or fracture of the appliance and health of adjacent gingiva during a one-year follow up
Wear of the opposing teeth
Detailed Description: After extraction of the mandibular first primary molars in both mandibular quadrants impressions will be taken with intraoral scanner Then it will be sent to the CADCAM laboratory to construct functional band and loop space maintainers using PEEK and monolithic zirconia BruxZir blocks with proper shades

After the fabrication of the space maintainers of both sides they will be cemented with resin luting cement containing MDP monomer Photographs will be taken after cementation for the space maintainers and the patient will be informed and educated about the oral hygiene measures The parents will also be inquired to call if any discomfort debonding or fracture of the appliances happens

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None