跳至主要内容
临床试验/NCT06575062
NCT06575062已完成不适用

The Effect of Different Treatment Methods on Apical Closure and Treatment Success in Immature Permanent First Molars With Reversible Pulpitis

Ataturk University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Radiographic assessment after pulpotomy or direct pulp capping treatment

研究概览

简要总结

The purpose of this thesis study is to evaluate the clinical and radiographic success of direct capping and pulpotomy applications using ProRoot MTA (mineral trioxide aggregate) in lower permanent first molars with reversible pulpitis symptoms that have not yet completed their root development. Additionally, the study aims to assess the effects of these treatments on maturogenesis, specifically root development and apical closure.

详细描述

The objective of this thesis is to investigate the effectiveness of direct capping and pulpotomy treatments using ProRoot MTA in managing reversible pulpitis in lower permanent first molars that have not yet achieved full root development. This study focuses on assessing both clinical and radiographic outcomes of these dental procedures. Specifically, it aims to determine the impact of these treatments on the natural progression of root formation and the closure of the root apex, a process known as maturogenesis. By examining these factors, the study seeks to provide a comprehensive understanding of how ProRoot MTA can be utilized to facilitate proper root development and healing in immature permanent molars affected by reversible pulpitis.

The study will test the following hypotheses:

Hypothesis 1: There is no difference between the clinical and radiographic success of direct capping and pulpotomy treatments in cases of reversible pulpal involvement of immature permanent molars.

Hypothesis 2: In cases of reversible pulpal involvement of immature permanent molars, direct capping and pulpotomy treatments have no effect on apexogenesis.

Hypothesis 3: Different root development levels of the teeth have no effect on the success of direct capping and pulpotomy treatments in cases of reversible pulpal involvement of immature permanent molars.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
7 Years 至 10 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Ages ranging from 7 to 10 years.
  • •Systemically healthy individuals.
  • •Have symptomatic reversible pulpitis characterized by pain that starts spontaneously and does not subside for a long time but does not include throbbing or night pain.
  • •Patients with permanent mandibular molars exhibiting open root tips, classified as Moorrees stages R½, R¾, Rc, or A½.

排除标准

  • •Children with systemic diseases.
  • •Presence of signs indicative of pulp necrosis, such as fistula or swelling in the buccal/lingual region.
  • •Tenderness upon palpation in the buccal/lingual region.
  • •Pain upon percussion.
  • •Presence of interradicular or periradicular radiolucency on radiographic examination.
  • •Evidence of internal or external root resorption.
  • •Widening of the periodontal space.
  • •Teeth with caries or molar-incisor hypomineralization (MIH) that result in excessive material loss potentially leading to restoration failure.
  • •Patients with inflammation and hyperemia in the root pulp.
  • •Permanent mandibular molar teeth with closed or nearly closed root ends, classified as Moorrees stage Ac.

研究组 & 干预措施

Direct Capping

Active Comparator

The direct capping technique was applied when the pulp exposure was less than 2 mm. In this application, cavity disinfection was achieved with a 2.5% sodium hypochlorite solution due to the exposed pulp. After controlling the bleeding, the MTA was prepared according to the manufacturer's recommendations and placed on the exposed area. The MTA was then covered with resin-modified glass ionomer cement. To ensure proper bonding of the restorative material and a leak-proof restoration, material residues on the cavity walls were removed with a steel round bur. The cavity walls were roughened with 35% orthophosphoric acid. Following the application of a dentin bonding agent, the upper restoration was completed with composite resin using the layering technique.

干预措施: Direct Pulp Capping with ProRoot MTA (Procedure)

Pulpotomy

Active Comparator

In cases where the pulp exposure was more than 2 mm, the pulpotomy technique was employed. The procedure began with the removal of the pulp roof using steel round burs. The pulp was then amputated up to the pulp canal openings with a sterile sharp spoon excavator. Hemostasis was achieved using a sterile cotton pellet impregnated with physiological saline for 3-5 minutes. If hemostasis could not be achieved and inflammation had progressed to the root pulp, regenerative endodontics was applied. Once hemostasis was secured, the cavity was disinfected again with 2.5% sodium hypochlorite. A 2 mm thick layer of MTA was applied to the pulp base and covered with MTA resin-modified glass ionomer cement. The cavity walls were roughened with 35% orthophosphoric acid after removing material residues with a steel round bur. Following the application of a dentin bonding agent, the upper restoration was completed with composite resin using the layering technique.

干预措施: Pulpotomy with ProRoot MTA (Procedure)

结局指标

主要结局

Radiographic assessment after pulpotomy or direct pulp capping treatment

时间窗: 6 Month - 1 Year - 18 month

This outcome measure involves the radiographic evaluation of the treated tooth post-pulpotomy or direct pulp capping. The assessment focuses on the absence of root resorption (both internal and external), no furcation involvement, no periapical radiolucency, and no loss of lamina dura. Additionally, a normal appearance of the periodontal ligament space is expected. The natural progression of root formation and root apex closure, known as maturogenesis, will be monitored according to Moorrees classification (stages R½, R¾, Rc, A½, and Ac), ensuring the process follows this sequence.

Clinical success after pulpotomy or direct pulp capping treatment

时间窗: 6 Month - 1 Year- 18 month

This outcome measure evaluates the absence of pathological signs or symptoms in the treated tooth, including no abscess formation, no swelling, no fistula development, no abnormal mobility, and no post-operative pain. Additionally, the absence of pain on palpation or percussion of the tooth is assessed.

次要结局

未报告次要终点

研究者

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

Muhammed Alagöz

research assistant

Ataturk University

研究点 (1)

Loading locations...

相似试验

The Effect of Different Treatment Methods on the... | 临床试验