Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-03

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pediatric Dentistry

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

articipants will be blinded to the type of intervention. Teeth treated will be assigned codes so that outcome evaluators at the follow up appointments are blinded. On the other hand, the operator/ primary investigator cannot be blinded, as she is already familiar with the nature of the materials used. For statistical analysis, codes will also assure blinding and confidentiality. For the patient, both types of space maintainers will have the same color and design.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

aesthetic functional space maintainers

Intervention Type OTHER

evaluate the use of Polyetheretherketone 'PEEK' and monolithic zirconia 'Bruxzir' as esthetic functional band and loop space maintainers.

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

Group Type ACTIVE_COMPARATOR

aesthetic functional space maintainers

Intervention Type OTHER

evaluate the use of Polyetheretherketone 'PEEK' and monolithic zirconia 'Bruxzir' as esthetic functional band and loop space maintainers.

Interventions

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aesthetic functional space maintainers

evaluate the use of Polyetheretherketone 'PEEK' and monolithic zirconia 'Bruxzir' as esthetic functional band and loop space maintainers.

Intervention Type OTHER

Eligibility Criteria

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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

* 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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes