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临床试验/NCT04636450
NCT04636450Unknown不适用

Comparison Between Manual and Rotatory Instrumentation Pulpectomy Treatments in Primary Mandibular Molars

Universidad de Guanajuato2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Instrumentation time

研究概览

简要总结

In this study, the aim is to compare manual and rotatory pulpectomy techniques on 100 primary mandibular molars on children between the ages of 4 and 8 years. The plan is to conduct a randomized controlled trial with a 1:1 ratio for group allocation at a teaching university pediatric dentistry clinic between January 2021 and December 2021. Two manual systems, as well as two rotary systems, will be randomly assigned. The adult manual system used will be K-file and the adult rotary system will be K3. The pediatric manual system used in this study will be Kedo-SH, while the pediatric rotary system will be Kedo-S. The observed outcome measures in this study are the following: 1) instrumentation and filling time; 2) filling quality by radiographic evaluation; 3) postoperative pain levels using the visual analog scale at 12 and 24 hours; and 4) frequency of complications (e.g. fistulas, thinning of the mesiodistal walls, periapical or furcation radiolucency) after a 3-, 6-, 9-, and 12-month follow-up.

详细描述

Introduction

Dental caries is a prevalent chronic disease, affecting 60-90% of school-age children in industrialized countries; although in the last four decades the prevalence and severity of caries lesions have decreased, it is still a frequent disease for this age group. The American Dental Association (ADA) classifies dental caries by clinical presentation as initial, moderate, and severe; furthermore, the ADA classifies the disease using the international caries detection and diagnosis system (ICDAS II; International Caries Detection and Assessment System II) and by a radiographic presentation of the proximal faces based on the E0-E2, D1-D3 notation system. Within the non-vital pulp treatments, pulpectomy is indicated in temporary teeth; pulpectomy is a conventional endodontic treatment for teeth with exposed, infected, and/or necrotic tissue to eliminate pulp and periradicular infection.

In a recent systematic review that compared three different strategies for the management of deep caries lesions (i.e. complete caries removal, selective caries removal, and step caries removal), Aïem and colleagues (2020) report an increased restoration failure risk when selective removal is used compared to complete removal of caries. In a study where French dentists were surveyed on the management of deep caries lesions in primary dentition, the majority of respondents mentioned performing deep caries removal in a single step. Endodontic procedures in the pediatric population can assist to keep temporary teeth until exfoliation, which is a key principle of pediatric dentistry. Vital pulp and non-vital pulp treatments are employed in the treatment of severe lesions and deep caries; meanwhile, pulpectomy is a treatment largely used in the primary dentition. In pulp therapy, a pulpotomy is performed by removing the pulp from the chamber, while in a pulpectomy, all the tissue from both the chamber and the root canals is removed.

There are two parameters used to determine root canal treatment success: 1) the morphology and shaping of the canal; and 2) the duct cleanliness or the adequate level of disinfection provided by the type and quantity of intra-canal irrigation (e.g. chlorhexidine, sodium hypochlorite, citric acid, profuse irrigation). A pulpectomy is the technique of choice for primary dentition in deep carious lesions with pulp necrosis since pulpectomy has a higher success rate than pulpotomy. While the time for access to the root canal is less with the use of rotary instrumentation systems compared to a manual technique, manual techniques have the same efficacy as rotary systems in root canal cleaning procedures. Rotary systems have greater clinical success compared to manual techniques, in addition to having advantages in instrumentation time, canal shaping, reduction in working time, better cooperation and less patient fatigue, improvement in the conicity of the root canal, and promoting a higher quality of obturation. In a recent meta-analysis, Manchanda and colleagues (2020) conclude that rotary instrumentation has similar clinical and radiographic success rates to manual techniques in primary dentition; additionally, rotatory techniques show lower levels of postoperative pain and less instrumentation time. In the only study in the Mexican population that compared a rotary system (i.e. K3) against a manual technique (i.e. K-file) it was found that the instrumentation and obturation time was shorter, being a promising technique in children.

Given the limited comparative literature about rotatory techniques used in pulpectomy treatment, it is necessary to conduct clinical trials that compare both manual and rotatory techniques in first dentition treatment. So far, studies have been carried out comparing rotary systems designed for adults in the pediatric population. Recently, interest to validate and implement safe and effective protocols for the management of rotary systems in primary dentition has emerged in pediatric dentistry. Below is a protocol designed to investigate the advantages and disadvantages associated with the use of rotary systems designed for our population of interest.

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
Single (Outcomes Assessor)

盲法说明

Only the outcome assessor will be blinded as the interventions can not be blinded to the participant and care provider.

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients between 4 to 8 years old.
  • Both genders.
  • Patients with an indication for pulpectomy for mandibular molars, based on the of Kuo and colleagues criteria (2006).
  • Patients requiring pulpectomy in posterior teeth.
  • Adequate dental structure of the crown.
  • Patients with a remnant structure of at least two-thirds of the root.
  • Patients with a medical file at the Pediatric Dentistry Clinic, Universidad Latinoamericana, Campus Valle.
  • Patients with signed informed consent.

排除标准

  • Patients requiring pulpotomy, extraction, or pulp regeneration therapy.
  • Patients who are older than 9 years.
  • An unrestorable tooth.
  • Internal resorption in the roots visible on radiographs.
  • Teeth with mechanical or carious perforations of the floor of the pulp chamber.
  • Excessive pathologic root resorption involving more than a third of the root.
  • Excessive pathologic loss of bone support, with loss of the normal periodontal attachment.
  • Presence of a dentigerous or follicular cyst.
  • Periapical or interradicular lesion involving the crypt of the developing permanent successor.
  • Patients with the diagnosis of molar incisor hypomineralization (MIH).
  • Patient's whose legal guardian does not provide their informed consent to participate in this study.
  • Uncooperative patients.
  • Elimination criteria
  • a. Patients who do not complete the treatment or radiographic follow-up at least at a cut-off point.

结局指标

主要结局

Instrumentation time

时间窗: Minutes; intraoperative time.

The time needed to shape the root canal.

Obturation time

时间窗: Minutes, intraoperative time.

Time needed to obturate the root canals.

Filling quality

时间窗: Immediately after surgical procedure.

Radiographic evaluation of the root canal filling.

Postoperative pain

时间窗: 24 hours

Pain resulting from the surgical procedure, evaluated with the visual analog pain scale (range, 1 to 10; the higher the score the worst the outcome).

次要结局

  • Complications secondary to procedure(12-months)

研究者

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

Jaime Daniel Mondragón Uribe

Medical researcher

Universidad de Guanajuato

研究点 (2)

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