Clinical Evaluation of Conventional Prefabricated and 3D-Printed Band and Loop Space Maintainers in Children: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- prefabricated maintainers offer superior durability in terms of survival rate
研究概览
简要总结
The present study aimed to evaluate and compare the clinical performance of three types of band and loop space maintainers - Conventional, Pre-fabricated and 3D-printed over a 9-month follow-up period in pediatric patients. The evaluation was based on three key clinical parameters: gingival health, patient and parent acceptance, and appliance survival rate.
Throughout the study, gingival health remained favorable across all groups, with the 3D-printed and Conventional space maintainers maintaining 100% normal gingiva. A slight gingival response (10% mild gingivitis) was noted only in the Pre-fabricated group at the 9th month. This suggests that all three designs, when placed correctly and maintained properly, are biocompatible and gingiva-friendly.
In terms of patient and parent acceptance, 3D-printed space maintainers consistently received the highest satisfaction ratings, with no discomfort reported at any follow-up. This can be attributed to the customized fit and smooth finish achieved through digital fabrication. On the other hand, initial discomfort was observed in both the prefabricated and Conventional groups at the 1-month follow-up, likely due to band tightness or adjustment issues.
Regarding the survival rate, the Pre-fabricated space maintainers performed the best, showing 100% retention over 9 months. The Conventional group followed closely, while the 3D-printed group showed minor early debonding issues, though these were not statistically significant and were likely due to adaptation challenges or bonding technique. Despite these, all three groups demonstrated generally good clinical longevity.
Overall, the study highlights that each type of space maintainer has its own set of advantages. While Pre-fabricated maintainers are quick to place and highly durable, 3D-printed maintainers excel in comfort, gingival response, and digital precision. Conventional maintainers remain a dependable option but are more technique-sensitive and require lab work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •systemically healthy children aged 4–8 years with early loss of primary molars due to caries or non-restorable lesions, presence of sound adjacent teeth, and radiographic confirmation of a developing permanent successor with at least 1 mm of bone coverage and less than one-third of root formation.
排除标准
- •if they had poor oral hygiene, grossly carious adjacent teeth, local oral pathology, systemic conditions, or if they or their parents declined participation.
结局指标
主要结局
prefabricated maintainers offer superior durability in terms of survival rate
时间窗: Follow-up visits were scheduled at 1st, 3rd, 6th, and 9th months to assess survival time, gingival health, and acceptance
次要结局
- secondary outcomes included gingival health evaluated using the Silness and Loe Gingival Index (1963), patient and parent acceptance assessed through the Likert scale (1932), and clinical fit and occlusal harmony evaluated at insertion and subsequent follow-ups.(Follow-up visits were scheduled at 1st, 3rd, 6th, and 9th months to assess gingival health, and acceptance)
研究者
KANNEGANTI HIMASREE
MNR DENTAL COLLEGE AND HOSPITAL