Evaluation of Crown Fractures in Permanent Teeth Following Dental Trauma Using the Modified Baysal Dental Trauma Index and Clinical Follow-Up of Their Treatments
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Proportion of Treated Teeth Without Clinical Symptoms or Radiographic Pathology at 12 Months (PAI Score ≤ 2)
研究概览
简要总结
This study will be conducted by the Department of Pediatric Dentistry, Faculty of Dentistry, İnönü University, with the aim of evaluating the treatment processes and follow-up responses of patients aged between 6 and 14 years who will present with crown fractures in their maxillary or mandibular permanent incisors.
Written informed consent will be obtained from the parents of all participating patients. The research will be carried out using a prospective observational design.
Initially, sociodemographic information as well as personal data such as the child's age and gender will be collected through a questionnaire designed for the parents. Additionally, trauma-related information-including the time, location, and cause of the injury-will be recorded in detail using a trauma assessment form developed for the study.
Each patient will undergo clinical and radiographic evaluations, and treatment planning and follow-up will be carried out based on these findings.
详细描述
The sample size was determined based on a statistical power analysis. This analysis was conducted with an effect size of w = 0.5, an alpha error probability of α = 0.05, and a power of 1 - β = 0.8. Calculations performed for two degrees of freedom (df = 2) yielded a total required sample size of 39 participants.
Inclusion Criteria:
Age between 6 and 14 years Presence of a traumatic dental injury in a permanent tooth Type of TDI classified as either complicated or uncomplicated crown fracture Consent to participate provided by the patient's legal guardian
Exclusion Criteria:
Patients outside the 6-14 age range or presenting for other reasons Patients with traumatic dental injuries other than crown fractures
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 and 14 years
- •Presence of traumatic dental injury involving a permanent tooth
- •Type of injury classified as a complicated or uncomplicated crown fracture
- •Informed consent obtained from the patient's parent or legal guardian
排除标准
- •Patients younger than 6 or older than 14 years, or those presenting for non-trauma-related dental issues
- •Patients with traumatic dental injuries other than crown fractures (e.g., luxation, avulsion)
研究组 & 干预措施
Dental Trauma - Crown Fracture Group
This arm includes children aged 6 to 14 years who present with crown fractures due to dental trauma. Treatment modality (direct composite restoration, Cvek pulpotomy, or endodontic therapy) will be selected based on clinical and radiographic findings. All patients will be followed over time to assess treatment outcomes.
干预措施: Direct Composite Restoration (Procedure)
Dental Trauma - Crown Fracture Group
This arm includes children aged 6 to 14 years who present with crown fractures due to dental trauma. Treatment modality (direct composite restoration, Cvek pulpotomy, or endodontic therapy) will be selected based on clinical and radiographic findings. All patients will be followed over time to assess treatment outcomes.
干预措施: Cvek Pulpotomy (Procedure)
Dental Trauma - Crown Fracture Group
This arm includes children aged 6 to 14 years who present with crown fractures due to dental trauma. Treatment modality (direct composite restoration, Cvek pulpotomy, or endodontic therapy) will be selected based on clinical and radiographic findings. All patients will be followed over time to assess treatment outcomes.
干预措施: Endodontic Treatment (Procedure)
Dental Trauma - Crown Fracture Group
This arm includes children aged 6 to 14 years who present with crown fractures due to dental trauma. Treatment modality (direct composite restoration, Cvek pulpotomy, or endodontic therapy) will be selected based on clinical and radiographic findings. All patients will be followed over time to assess treatment outcomes.
干预措施: Pulp Capping (Procedure)
结局指标
主要结局
Proportion of Treated Teeth Without Clinical Symptoms or Radiographic Pathology at 12 Months (PAI Score ≤ 2)
时间窗: 12 months
Treatment success will be defined as the absence of spontaneous pain, swelling, sinus tract, abnormal mobility, discoloration, and the presence of radiographic healing or absence of periapical pathology, as assessed using the Periapical Index (PAI) by Ørstavik et al. (1986). Evaluations will be performed at 12 months post-treatment.
次要结局
- Change in Periapical Index (PAI) Score From Baseline to 12 Months(12 months)
研究者
Tuba Aydan
Pediatric Dentistry Specialist, Principal Investigator
Inonu University