Glass Fiber-Reinforced Composite Resin Versus Band-and-Loop Space Maintainers in Children: A Split-Mouth Clinical Study

Overview

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.

Premature loss of primary molars may result in undesirable tooth movement, arch length reduction, and subsequent malocclusion. Space maintainers are routinely used to preserve arch integrity until eruption of the permanent successor. The conventional band-and-loop (B\&L) appliance is considered the standard fixed space maintainer; however, it requires laboratory fabrication, multiple clinical visits, and may be associated with cement failure and esthetic limitations. Glass fiber-reinforced composite resin (GFRCR) space maintainers have emerged as a minimally invasive, esthetic alternative that can be fabricated directly in a single clinical visit without laboratory procedures. Nevertheless, evidence regarding their long-term clinical performance remains limited and inconsistent. This prospective split-mouth comparative clinical trial will enroll 20 children aged 5-8 years presenting with bilateral premature loss of comparable primary molars at the Pediatric Dentistry Clinic, Faculty of Dentistry, Najran University, Saudi Arabia. Each participant will receive a GFRCR space maintainer in one quadrant (test intervention) and a conventional B\&L appliance in the contralateral quadrant (control intervention), allowing each child to serve as his or her own control and minimizing inter-individual variability. Before appliance placement, all participants will undergo comprehensive clinical and radiographic examinations, professional oral prophylaxis, and any required restorative treatment. Clinical follow-up examinations will be performed after 3, 6, and 9 months. The primary outcome is appliance retention (survival). Secondary outcomes include: Gingival health around the abutment teeth (Gingival Index). Development of dental caries (International Caries Detection and Assessment System, ICDAS). Preservation of extraction space measured using a Boley gauge. Statistical analyses will be performed using paired statistical methods appropriate for the split-mouth design, including the McNemar test for paired categorical outcomes and the Log-rank test for appliance survival analysis. Statistical significance will be established at p \< 0.05. This study will provide clinical evidence regarding the effectiveness of esthetic glass fiber-reinforced composite resin space maintainers compared with the conventional band-and-loop appliance and may support their wider adoption in pediatric dental practice.