Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children

Ain Shams University20 enrolled

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Pediatric Dentistry

Interventions

aesthetic functional space maintainersOTHER

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

Clinical performance

regarding debonding or fracture of the appliance. if debonding or fracture occur then this means failure.

Time frame: 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.

Time frame: 1 year

Secondary Outcomes

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

Time frame: 1 year

Central Contacts

Hagar Abozeid, PhD

CONTACT

0201110611169 Hagar_abozeid_22@hotmail.com

Mariem Wassel, Professor

CONTACT

01064871416

Data from ClinicalTrials.gov

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