An interventional study of Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer and Conventional Band-and-Loop Space Maintainer in Premature Loss of Primary Teeth, Space Maintenance and Malocclusion, sponsored by Ali Assiry. Completed at 1 site in Saudi Arabia. Open to participants aged 5 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Ali Assiry · Not applicable, Interventional, and Treatment
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.
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's enrollment of 20 is below the median of 36 across 372 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →This is the only study on the registry with Ali Assiry as lead sponsor.
Counted across the registry records on this site, refreshed daily.
No measurable space loss at the extraction sites. Presence of suitable mesial and distal abutment teeth adjacent to the edentulous space.
Buccal surfaces of abutment teeth free of dental caries. Class I occlusion or normal primary molar relationship. Presence of succedaneous permanent teeth with no more than one-half of root formation.
Root resorption of the abutment teeth involving less than one-third of the root length.
Presence of the bony crypt over the succedaneous tooth germ. Written informed consent obtained from a parent or legal guardian.
Exclusion Criteria:
Root resorption of abutment teeth exceeding one-third of the root length. Advanced development or absence of the permanent successor. Inability to attend scheduled follow-up visits or lack of parental consent.
Participants received a directly bonded glass fiber-reinforced composite resin (GFRCR) space maintainer in one quadrant following premature loss of a primary molar. Each participant also received the comparator intervention in the contralateral quadrant as part of the split-mouth study design.
Device: Glass Fiber-Reinforced Composite Resin (GFRCR) Space Maintainer
Participants received a conventional stainless-steel band-and-loop (B\&L) space maintainer in the contralateral quadrant following premature loss of a primary molar. Each participant also received the experimental intervention in the opposite quadrant.
Device: Conventional Band-and-Loop 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.
Also known as: GFRCR
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.
Appliance retention (survival rate)
Comparison of the clinical survival and retention of glass fiber-reinforced composite resin (GFRCR) and conventional band-and-loop (B\&L) space maintainers.
Time frame: 3, 6, and 9 months after appliance placement
Gingival health
Gingival condition around the abutment teeth assessed using the Löe and Silness Gingival Index.
Time frame: 3, 6, and 9 months after appliance placement
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication, including demographic characteristics, clinical outcomes, and follow-up data.
Supporting information: Study protocol, Sap
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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