跳至主要内容
临床试验/NCT07827833
NCT07827833招募中不适用

Clinical Outcomes and Failure Rates of Restorative Treatments Following Full-Mouth Dental Rehabilitation Under General Anesthesia in Children

Tanta University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年8月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
1
主要终点
Restoration Failure Rate Over 24 Months

研究概览

简要总结

Full-mouth dental rehabilitation under general anesthesia (GA) is frequently required for young children with extensive dental caries, behavioral challenges, or special healthcare needs. Although various restorative materials and treatment approaches are used during comprehensive dental rehabilitation, evidence regarding their long-term clinical performance and failure rates remains limited. Objective: This prospective cohort study aims to evaluate the clinical outcomes and failure rates of restorative materials and methods employed during full-mouth dental rehabilitation under general anesthesia in children over a two-year follow-up period. Methods: Children undergoing full-mouth dental rehabilitation under general anesthesia will be enrolled and followed prospectively for 24 months. Restorative procedures, including direct and indirect restorative treatments, pulp therapy-associated restorations, and full-coverage restorations, will be performed according to standardized clinical protocols. Clinical evaluations will be conducted at scheduled follow-up visits to assess restoration survival, integrity, recurrent caries, need for retreatment, and restoration failure. Failure rates and factors associated with restoration success or failure will be analyzed.

详细描述

Early childhood caries and extensive dental disease remain significant oral health problems among children worldwide. In many cases, comprehensive dental treatment under general anesthesia (GA) is required to manage young children who exhibit extensive treatment needs, lack of cooperation, dental anxiety, behavioral limitations, or special healthcare needs. Full-mouth dental rehabilitation under GA enables the delivery of comprehensive restorative and preventive dental care in a single session, improving oral health and quality of life for affected children. A variety of restorative materials and treatment methods are routinely employed during pediatric dental rehabilitation under GA, including resin composite restorations, glass ionomer-based restorations, stainless steel crowns, esthetic full-coverage crowns, and restorations associated with pulp therapy procedures. Despite their widespread use, the long-term clinical performance and survival of these restorative approaches may vary according to material characteristics, tooth type, extent of carious destruction, patient-related factors, and oral hygiene practices. Restoration failure may result from recurrent caries, loss of restoration, marginal deterioration, fracture, wear, or the need for replacement or retreatment.

Although several studies have evaluated restorative outcomes in pediatric patients, evidence comparing the long-term success and failure rates of restorative materials and techniques used during full-mouth dental rehabilitation under GA remains limited. Furthermore, most available studies have reported variable follow-up periods and heterogeneous outcome measures, making it difficult to establish evidence-based recommendations for restorative treatment selection.

The purpose of this prospective cohort study is to evaluate the clinical outcomes and failure rates of restorative materials and methods employed during children's full-mouth dental rehabilitation under general anesthesia over a two-year follow-up period. Children receiving comprehensive dental treatment under GA will be enrolled and monitored at predetermined follow-up intervals. Clinical assessments will evaluate restoration survival, retention, marginal integrity, recurrent caries, restoration fracture, need for repair or replacement, and overall treatment success. The cumulative survival and failure rates of different restorative materials and treatment methods will be determined, and factors associated with restoration longevity will be investigated.

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 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children requiring comprehensive/full-mouth dental rehabilitation under general anesthesia because of extensive dental treatment needs.
  • Children receiving restorative and/or full-coverage dental treatments as part of routine clinical care.
  • Children whose parents provide written informed consent for participation and follow-up.
  • Children whose planned treatment allows clinical evaluation of the restorations for the intended 24-month follow-up period.
  • Children whose parents or legal guardians are willing and able to attend the scheduled follow-up visits for up to 24 months.

排除标准

  • Children for whom the planned dental rehabilitation cannot be completed because of medical or anesthetic considerations.
  • Children with systemic or medical conditions that are expected to substantially affect oral healing, caries progression, or restoration survival.
  • Children unlikely to attend or complete the scheduled 24-month follow-up.
  • Children with inadequate clinical records or insufficient baseline information required for assessment of restoration outcomes.

研究组 & 干预措施

Children Undergoing Full-Mouth Dental Rehabilitation Under General Anesthesia

Children undergoing full-mouth dental rehabilitation under general anesthesia as part of routine clinical care will be prospectively enrolled and followed for 24 months. Restorative materials and treatment methods will be selected by the treating clinicians according to the child's clinical condition, tooth type, extent of caries, remaining tooth structure, pulp status, and standard clinical indications. No restorative material or treatment method will be assigned by the study investigators. The clinical performance, survival, and failure of restorations placed during routine treatment will be evaluated at scheduled follow-up visits over a two-year period.

干预措施: Routine Restorative Materials and Treatment Methods (Other)

结局指标

主要结局

Restoration Failure Rate Over 24 Months

时间窗: Baseline to 24 months

The proportion of restorations that experience failure during the 24-month follow-up period. Restoration failure will include recurrent caries, loss or debonding of the restoration, fracture, unacceptable marginal deterioration, or the need for restoration replacement, repair, or retreatment.

次要结局

  • Cumulative Restoration Failure Rate According to Restorative Material(3, 6, 12, 18, and 24 months)
  • Types of Restoration Failure(3, 6, 12, 18, and 24 months)
  • Restoration Failure According to Tooth Type and Location(3, 6, 12, 18, and 24 months)
  • Overall Treatment Success Following Full-Mouth Dental Rehabilitation(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaimaa Shaban Mohamed El-desouky

assistant professor of pediatric dentistry

Tanta University

研究点 (1)

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