Evaluation of PEEK and BruxZir as Esthetic Space Maintainers in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: aesthetic functional space maintainers.
- Who it may be relevant to
- Registry conditions: Pediatric Dentistry. Basic parameters: 6 years — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Polyetheretherketone and Monolithic Zirconia as Esthetic Functional Space Maintainers in Children (A Randomized Clinical Trial)
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.
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.
Interventions
- Other aesthetic functional space maintainers
evaluate the use of Polyetheretherketone 'PEEK' and monolithic zirconia 'Bruxzir' as esthetic functional band and loop space maintainers.
Primary outcome measures
- Clinical performance [Time frame: 1 year]
- Gingival health [Time frame: 1 year]
Secondary outcome measures (1)
- Wear of the opposing tooth [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Ain Shams University — Cairo
Identifiers
NCT: NCT06558968 · PED21-8D