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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Appliance retention (survival rate)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-8 years. Bilateral premature loss of comparable primary molars indicated for extraction or recently extracted.
- •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.
排除标准
- •Existing space loss at the extraction site. Pathological lesions involving the jaws or teeth. Malocclusion or abnormal oral musculature. Systemic diseases or medical conditions affecting dental treatment. Abutment teeth with dental caries or inadequate structure for appliance placement.
- •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.
结局指标
主要结局
Appliance retention (survival rate)
时间窗: 3, 6, and 9 months after appliance placement
Comparison of the clinical survival and retention of glass fiber-reinforced composite resin (GFRCR) and conventional band-and-loop (B\&L) space maintainers.
次要结局
- Gingival health(3, 6, and 9 months after appliance placement)
研究者
Ali Assiry
Assistant Professor of Pediatric Dentistry
Najran University