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Glass Fiber-Reinforced Composite Resin Versus Band-and-Loop Space Maintainers in Children: A Split-Mouth Clinical Study
Sponsor: Ali Assiry
Summary
This split-mouth randomized clinical study aims to compare the clinical performance of glass fiber-reinforced composite resin (GFRCR) space maintainers with conventional band-and-loop (B\&L) space maintainers following premature loss of primary molars in children. Twenty children aged 5-8 years with bilateral premature loss of comparable primary molars will receive a GFRCR appliance on one side of the dental arch and a conventional B\&L appliance on the contralateral side. Participants will be evaluated at 3, 6, and 9 months for appliance retention, gingival health, dental caries around the abutment teeth, and preservation of the extraction space. The study aims to determine whether GFRCR space maintainers provide clinical performance comparable to conventional B\&L appliances while offering the advantages of improved esthetics and single-visit placement.
Official title: Clinical Performance of Glass Fiber-Reinforced Composite Resin Versus Conventional Band-and-Loop Space Maintainers Following Premature Loss of Primary Molars: A Split-Mouth Comparative Study
Key Details
Gender
All
Age Range
5 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-04-25
Completion Date
2026-07-20
Last Updated
2026-07-28
Healthy Volunteers
No
Interventions
Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer
A directly bonded fixed space maintainer fabricated using Splint-it® glass fiber-reinforced composite resin. The appliance was placed in a single clinical visit to preserve the extraction space following premature loss of a primary molar.
Conventional Band-and-Loop Space Maintainer
A conventionally fabricated stainless-steel band-and-loop fixed space maintainer cemented onto the abutment tooth to preserve the extraction space following premature loss of a primary molar.
Locations (1)
Pediatric Dentistry Clinic, Faculty of Dentistry, Najran University
Najran, Najran Region, Saudi Arabia