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临床试验/NCT06874062
NCT06874062已完成不适用

Clinical and Radiographic Evaluation of the Success of Resin-Modified Calcium Silicate in Primary Tooth Pulpotomy

Ataturk University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年6月20日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Clinical Success

研究概览

简要总结

The goal of this clinical trial is to evaluate whether Theracal PT, a resin-modified calcium silicate-based material, can be successfully used in pulpotomy treatment for primary molar teeth. The efficacy of this material will be compared with MTA in its putty form (Neoputty) and powder-liquid form (ProRoot). The main questions this study aims to answer are: Is Theracal PT as effective as MTA, the gold standard for pulpotomy treatment? Is Neoputty MTA, which is easier to handle, more effective than ProRoot MTA? The study will include systemically healthy children aged 4 to 9 years with at least one primary molar requiring pulpotomy. Treated teeth will be evaluated clinically and radiographically at 3, 6, and 12 months.

详细描述

Tooth decay is a complex process of enamel demineralization and remineralization caused by organic acids produced by microorganisms in the dental plaque. When this balance shifts in favor of demineralization, caries formation occurs. Initially, decay begins with small surface roughness or subsurface demineralization, followed by cavitation and subsequent pulp involvement.

Tooth decay, one of the most common chronic diseases in childhood, negatively impacts the quality of life when left untreated, leading to problems such as pain, abscess formation, tooth loss, nutritional deficiencies, and speech disorders. To prevent early loss of primary teeth and maintain the health of the oral and surrounding tissues, restorative or endodontic treatments are applied. Treatment methods for deep dentin caries in primary teeth include indirect pulp capping, direct pulp capping, and amputation, with amputation being the most commonly used vital pulp therapy. Amputation is indicated when the pulp is either healthy or reversibly damaged and shows no signs of pulp degeneration, and the pulp becomes exposed during caries removal due to decay or mechanical causes. The goal of treatment is to preserve the vitality of the radicular pulp, control pain and inflammation, and maintain the tooth until its physiological exfoliation time. The selection of appropriate materials and techniques for amputation therapy is of critical importance. Although several studies have investigated the success of amputation materials and techniques, the ideal amputation material has not yet been defined. The ideal material and technique should be bactericidal, harmless to the pulp and surrounding tissues, support the healing of the root pulp, and contribute to the preservation of remaining tissues without affecting physiological root resorption. Additionally, factors such as cost and ease of application should also be considered in material selection. Therefore, efforts to identify the ideal amputation material continue.

The aim of this study is to evaluate the clinical and radiographic success of Theracal PT®, ProRoot® MTA, and Neoputty® MTA, and to examine the relationship between these outcomes and factors such as age, gender, the position of the tooth in the arch, and the presence of provoked pain prior to treatment.

The following hypotheses were proposed in our study:

Hypothesis 1: There is no difference in the 12-month clinical and radiographic success rates of primary tooth amputation treatments performed using Neoputty® MTA, ProRoot® MTA, and Theracal PT®.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Deep dentin caries,
  • Lamina dura and periodontal interval can be observed normally,
  • 2/3 of the root length is present,
  • The permanent tooth germ below is present and its position is normal,
  • If there is a history of provoked pain (the type of pain that goes away when the stimulus is removed),
  • If there is a history of pain (short-term provoked pain, the pain goes away when the stimulus is removed,
  • Teeth with mechanical perforation larger than a needle tip in the perforation area or perforated with caries,
  • Teeth with light-colored bleeding and easily controlled within 3-5 minutes,
  • Teeth that can be restored with PÇK were included in the study

排除标准

  • Lesions in the inter-root and periapical region,
  • Pathological external or internal root resorption,
  • Canal calcification,
  • Deformities such as taurodontism,
  • Spontaneous pain or night pain,
  • Structural anomalies,
  • Abscess, swelling or fistula,
  • Pathological mobility,
  • Sensitivity to palpation and percussion,
  • Infraocclusion,
  • Dark, intense bleeding in the canal orifices

结局指标

主要结局

Clinical Success

时间窗: 1 Month - 1 Year

No spontaneous, provoked (developing due to a stimulus) or night pain complaints. No sensitivity to percussion or palpation. No pathological mobility in the tooth. No abscess or fistula in the tooth. If any of these findings are detected, the treatment is considered clinically unsuccessful.

Radiographic Success

时间窗: 3 Month - 1 Year

No internal or external root resorption. No periapical or inter-root lesion. No widening of the periodontal space. If any of these findings are detected, the treatment is considered radiographically unsuccessful.

次要结局

  • The Impact of Patient's Gender on 12-Month Radiographic Success of Treatment.(From treatment to the end of 12 months)
  • The Impact of Patient's Age on 12-Month Radiographic Success of Treatment.(From treatment to the end of 12 months)
  • The Impact of Tooth Position in the Dental Arch on the 12-Month Radiographic Success of Treatment(From treatment to the end of 12 months)
  • The Impact of Pre-Treatment Provoked Pain on the 12-Month Radiographic Success of Treatment.(From treatment to the end of 12 months)

研究者

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

Rabia Yücel

Research Assistant

Ataturk University

研究点 (2)

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