Soft Tissue Complications and Clinical Decision-Making in Distal Shoe Therapy: A Prospective Clinical Follow-Up Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence and severity of soft tissue complications adjacent to the distal shoe appliance
研究概览
简要总结
Distal shoe space maintainers are the standard of care for guiding the eruption of permanent first molars following the premature loss of the primary second molars. Although this therapy represents established clinical practice, prospective evidence regarding soft tissue complications and predictors of treatment outcomes remains limited. This observational study will prospectively collect clinical outcome data during routine treatment visits. The aims of the study are to characterize patterns of complications, evaluate outcomes related to patient adherence, and identify predictors of treatment success. Ultimately, this study seeks to support the development of standardized strategies for clinical monitoring and complication management.
详细描述
The premature loss of a primary second molar prior to the eruption of the permanent first molar represents a significant clinical challenge in pediatric dentistry. Without appropriate intervention, the unerupted permanent first molar invariably drifts mesially during its eruptive path, resulting in severe arch length deficiency, impaction of the permanent second premolar, and complex malocclusions. The distal shoe space maintainer is the definitive intervention for these cases; its subgingival guide plane acts as a critical buttress, directing the permanent first molar into its correct anatomical position.
Despite its status as a standard clinical procedure, standardized clinical monitoring protocols and evidence-based complication management strategies remain limited. Current literature is primarily restricted to case reports and small retrospective series characterized by substantial heterogeneity in appliance design, follow-up intervals, and criteria for clinical success. Consequently, existing data offer descriptive or anecdotal observations rather than robust, prospective evidence. This gap in the literature leaves several critical clinical concerns unresolved:
Histological and Soft Tissue Ambiguity: Because the appliance's distal extension penetrates the gingival epithelium, it creates a potential pathway for bacterial ingress. There is a significant dearth of prospective data regarding long-term gingival health, the nature of the epithelial attachment, and the chronic inflammatory response at the subgingival metal interface.
Non-Standardized Complication Management: Clinicians currently lack a universal framework or validated assessment tool for managing prevalent complications, such as localized gingival inflammation, ulceration, appliance fracture, or cement failure.
Uncertain Predictors of Success: In the absence of systematic longitudinal monitoring, it remains difficult to quantify how patient-specific variables-specifically oral hygiene adherence and individual gingival reactivity-influence overall treatment success and post-operative morbidity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric participants aged 3 to 9 years
- •American Society of Anesthesiologists (ASA) Physical Status I or II
- •Clinical indication for distal shoe therapy as the standard of care
- •Undergoing distal shoe space maintainer placement
- •Parent or caregiver able to provide consent and comply with follow-up visits
排除标准
- •Presence of systemic medical conditions that may affect bone metabolism or wound healing
- •Patients unable or unwilling to comply with the planned follow-up schedule (up to 24 months)
- •Patients with contraindications to distal shoe therapy based on clinical judgment
研究组 & 干预措施
Distal Shoe Therapy Cohort
This cohort includes pediatric patients, aged 3 to 9 years (ASA I or II), for whom distal shoe therapy has been clinically indicated as the standard of care (SOC). Participants undergo routine appliance fabrication and placement as part of their standard clinical care. The cohort will be prospectively monitored during SOC follow-up visits (at 1-week and 3-month intervals) to evaluate soft tissue health, gingival inflammation, and the successful eruption of the permanent first molar. Individual participation typically ranges from 12 to 24 months.
干预措施: Standard Clinical Practice Regimen (Other)
结局指标
主要结局
Incidence and severity of soft tissue complications adjacent to the distal shoe appliance
时间窗: From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).
Assessment of the proportion of participants experiencing localized soft tissue complications and the graded severity of such responses. Evaluation includes the presence of gingival inflammation, ulceration, granulation tissue formation, or clinical signs of infection. These complications will be systematically documented during standardized clinical examinations at each follow-up visit. Severity will be categorized using a defined clinical scale (none, mild, moderate, severe). For participants with multiple symptoms, the overall severity will be reported based on the most severe clinical finding to arrive at one aggregated value per participant.
次要结局
- Frequency of missed follow-up appointments per participant(From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).)
- Adherence to oral hygiene instructions based on clinical assessment(From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).)
- Incidence of successful eruption guidance of the permanent first molar(From appliance placement until functional eruption of the permanent first molar (typically 12 to 24 months).)
研究者
Mi Sook Lee
Clinical Assistant Professor
University of Florida