Image

Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children

Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children

Recruiting
6-11 years
All
Phase N/A

Powered by AI

Overview

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.

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 CAD/CAM 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.

Eligibility

Inclusion Criteria:

  • Clinical inclusion criteria:
    • Children requiring bilateral extraction of mandibular first primary molars or those with previously extracted molars no more than 6 months prior to intervention (11) .
    • Existence of teeth on the mesial and distal side of edentulous area.
    • Angle's Class I molar relationship and/or flush terminal/mesial step primary molar occlusion

Radiographic inclusion criteria:

  • No periapical and/ or furcural pathological condition related to abutment teeth.
  • Presence of tooth germ of the succeeding tooth (mandibular first premolars).
  • Presence of more than 1 mm of bone overlying the successor tooth germ

Exclusion Criteria:

  • Carious abutment teeth requiring pulp therapy.
    • Carious abutment primary teeth requiring a full coverage restoration.
    • Patients with history of bruxism or/and clenching.
    • Patients with medical, intellectual or physical disabilities.
    • Patients with abnormalities as posterior cross-bite, open bite, and deep bite

Study details
    Pediatric Dentistry

NCT06558968

Ain Shams University

21 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.