Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children

Evaluation of Polyetheretherketone and Monolithic Zirconia as Esthetic Functional Space Maintainers in Children (A Randomized Clinical Trial)

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.

Study Overview

• Status: Recruiting
• Conditions: Pediatric Dentistry
• Intervention / Treatment: Other: aesthetic functional space maintainers

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hagar Abozeid, PhD; Phone Number: 0201110611169; Email: Hagar_abozeid_22@hotmail.com
• Study Contact Backup: Name: Mariem Wassel, Professor; Phone Number: 01064871416

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: polyetheretherketone; PEEK 'Polyetheretherketone' Victrex® is a type of polymer with suitable mechanical and physical properties. It is a resilient material with high flexural strength and resistance to deformation. Therefore, it can be used in fixed prosthesis and space maintainers	Other: aesthetic functional space maintainers; evaluate the use of Polyetheretherketone 'PEEK' and monolithic zirconia 'Bruxzir' as esthetic functional band and loop space maintainers.
Active Comparator: monolithic zirconia; BruxZir® is a type of monolithic zirconia with higher flexural strength and fracture toughness than the classic zirconia and can withstand the changes in temperature in the oral cavity. Therefore it can be used as a space maintainer	Other: aesthetic functional space maintainers; evaluate the use of Polyetheretherketone 'PEEK' and monolithic zirconia 'Bruxzir' as esthetic functional band and loop space maintainers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical performance	regarding debonding or fracture of the appliance. if debonding or fracture occur then this means failure.	1 year
Gingival health	Gingival Index of Loe and Silness. where score 0 indicates normal gingiva, score 1 mild inflammation (slight change in color, slight edema but no bleeding on probing. score 2 indicates moderate inflammation (redness, edema, bleeding on probing and score 3 refers to severe inflammation (marked redness, edema, ulceration with sponatnoeus bleeding.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wear of the opposing tooth	using CAD/CAM software Cerec software (Cerec 4.2, DentsplySirona, Bensheim, Germany)volumetric loss on the surfaces were calculated in the last follow up visit after 1 year	1 year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Nagwa Khattab, Professor, Ainshams U

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PED21-8D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No