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Evaluation of Polyetheretherketone and Monolithic Zirconia Versus Conventional Metal Band and Loop Space Maintainers in Children: A Randomized Split-Mouth Clinical Trial
Sponsor: Ain Shams University
Summary
Compare two tooth-colored CAD/CAM band and loop space maintainers, PEEK and monolithic zirconia (BruxZir), each against a conventional stainless-steel band and loop in children with premature loss of mandibular primary first molars. Two parallel arms (35 children each); within each arm, split-mouth design with the esthetic appliance on one side and the conventional appliance on the other. Outcomes: debonding or fracture, Plaque and Gingival Index, and patient comfort (Wong-Baker FACES) at 3, 6, 9 and 12 months.
Key Details
Gender
All
Age Range
5 Years - 7 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2023-10-03
Completion Date
2025-02-03
Last Updated
2026-10-30
Healthy Volunteers
No
Interventions
PEEK band and loop space maintainer
CAD/CAM-milled PEEK (CeraDirect) appliance designed in exocad, minimum thickness 1.5 mm. Fitting surface sandblasted with 50-micrometer aluminum oxide and treated with CeraBond primer; abutment tooth etched with 37% phosphoric acid; cemented with TheraCem resin cement.
BruxZir band and loop space maintainer
CAD/CAM-milled monolithic zirconia (BruxZir) appliance designed in exocad, minimum thickness 1.0 mm, sintered and glazed. Fitting surface sandblasted and treated with a zirconia primer; abutment tooth etched with 37% phosphoric acid; cemented with TheraCem resin cement
conventional stainless-steel band and loop space maintainer
Laboratory-made appliance with a prefabricated stainless-steel molar band and a 0.9-1.0 mm wire loop, silver-soldered and polished. Cemented with self-cure glass ionomer cement (GC Gold Label).
Locations (1)
Ain Shams University
Cairo, Egypt