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.
Inclusion Criteria:
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.
Clinical outcomes were evaluated by an independent examiner who was unaware of the allocation of the intervention to each quadrant whenever feasible. Due to the nature of the interventions, participants and treating clinicians could not be blinded.
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.
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.
Najran, Najran Region 55461, Saudi Arabia
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