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临床试验/NCT04685161
NCT04685161Unknown不适用

Comparison of Surgical Extrusion vs Fibre Post Restoration for Crown-root Fractured Maxillary Incisors. Randomized Clinical Trial

Tamil Nadu Dr.M.G.R.Medical University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2021年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
140
试验地点
1
主要终点
Radiographic healing of teeth is measured

研究概览

简要总结

A total of 124 samples was calculated to be sufficient with G*power software ver 3.1.9.2 with effect size of 0.4 alpha probability error and power 0.95.With drop out estimate of 10% the final sample size decided was 140 samples. Patients reporting with complicated(pulp exposed or pulpally involved) horizontal crown root fracture with loss of crown structure in maxillary incisors and radiograph evidence of supra alveolar tooth structure are recruited for study. Informed consent from the patients or guardian as appropriate is obtained as suitable prior to treatment delivery. Exclusion criteria were:patients not willing for recall visits, root with evidence of cervical resorption or roor canal filling, open apices, patient with systemic ailments rendering root canal treatment, compromised periodontal health, vertical or horizontal root fracture. Pulpal condition of tooth was assessed using cold sensibility test(Neosnow, orikam health care Ltd, India.) amd confirmed upon access opening with teeth showing evidence of pulpal bleeding wad categorized as irreversible pulpitis and teeth with no evidence of pulpal bleeding categorized as necrotic pulp.

详细描述

Patients are randomly alloted to treatment groups. Group I-Root canal treatment followed by surgical extrusion of teeth till about 40%supra gingival crown structure is visible clinically.

Group II-Root canal treatment followed by glass fibre post placement (Reforpost, Angelus, Brazil) and composite (charisma smart, Germany) core build up with porcelain fused metal crown.

Post treatment visits are scheduled 6,12,18 months, scheduled visits were planned as close as possible to the study protocol, but for the purpose of data collection, any recall visit occuring within plus or minus 10% of the advocated time was considered aa occuring at that time. Recall visit check up included clinical examination for mobility, periapical tenderness, gingival pocket depth estimation,bleeding on probing and radiographic examination. Patients are asked to report immediately of any unforeseen circumstances arises in the restored teeth.

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
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients with complicated crown root fracture
  • •patients willing for recall
  • •Good oral hygiene

排除标准

  • •patients not willing for recall
  • •Patients health rendering root canal treatment

研究组 & 干预措施

Surgical extrusion

Experimental

Novel and alternative treatment option for horizontal crown root fractured maxillary incisors

干预措施: Surgical extrusion (Procedure)

Fibre post

Active Comparator

Treatment modality normally used for crown-root fractured tooth

干预措施: Fibre post (Device)

结局指标

主要结局

Radiographic healing of teeth is measured

时间窗: 18 months

Periapical index score(PAI) is used for assessment

次要结局

未报告次要终点

研究者

发起方
Tamil Nadu Dr.M.G.R.Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rahul Baskar

Principal investigator

Tamil Nadu Dr.M.G.R.Medical University

研究点 (1)

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