Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children

Last updated: August 16, 2024
Sponsor: Ain Shams University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

aesthetic functional space maintainers

Clinical Study ID

NCT06558968
PED21-8D
  • Ages 6-11
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical inclusion criteria:

  • Children requiring bilateral extraction of mandibular first primary molars orthose with previously extracted molars no more than 6 months prior tointervention (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 primarymolar 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

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 Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: aesthetic functional space maintainers
Phase:
Study Start date:
January 03, 2024
Estimated Completion Date:
January 31, 2025

Study 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.

Connect with a study center

  • Ain Shams University

    Cairo,
    Egypt

    Active - Recruiting

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