跳至主要内容
临床试验/NCT03168620
NCT03168620已完成不适用

Evaluation of the Effect of Glass Ionomer Cement as an Interim Restoration in Diagnosis of Pulpal Status in Permanent Teeth: A Prospective Randomized Clinical Trial

Postgraduate Institute of Dental Sciences Rohtak0 个研究点目标入组 146 人开始时间: 2015年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
146
主要终点
clinical success

研究概览

简要总结

Aim: To evaluate whether glass ionomer interim therapeutic restoration (ITR) in asymptomatic teeth with deep cavities can help in determining the pulp status. Methodology: 146 mandibular molars with deep carious lesion having positive response to pulp sensitivity were randomly allocated to two study groups (75-ITR, 71- NON-ITR group). In the first group after partial caries removal(PCR), interim therapeutic restoration of glass ionomer cement (GIC) Ketac molar was placed for one month before definitive adhesive restoration. In NON-ITR group, cavity preparation was similar to ITR group, but definitive restoration was done in the same visit. Two examiners evaluated the clinical and radiographic outcomes for 18 months. Success was defined as absence of signs and symptoms of irreversible pulpitis and absence of periapical alterations.

详细描述

Introduction Preservation of pulp vitality while managing the deep carious lesions is often a great challenge and requires procedures like pulp capping and pulpotomy collectively termed as vital pulp therapy (VPT). Such treatment involves elimination of bacteria from pulp dentine complex and establishing an environment that will prevent any future bacterial contamination and improves survival prognosis. Management of deep carious lesions in recent years has changed from complete caries removal to partial caries removal. Partial caries removal has gained importance due to reduction in pulpal exposures, less postoperative complications, more preservation and maintenance of pulp tissue .

The important concern during VPT is accurate assessment of pulpal status. Methods to determine pulpal vitality include patient history, signs and symptoms, radiographs and pulp sensibility tests. One of the hallmarks of pulpal diagnosis is that it is difficult and has a high rate of inaccuracy. Pain on cold and hot stimuli cannot be considered as a reliable reference for making a treatment decision. Also insufficient evidence was found to determine the diagnostic accuracy of symptoms, signs, and diagnostic tests to assess the pulp status.

Studies using visual and histological inspection of exposed pulp to examine status of pulp reported marked variation in sensitivity of cold and electric pulp test from 0 .21 to 0.94, with relatively less variation in specificity from 0.73 to 0 .96.Sensitivity decreased to 67% when the spectrum of the disease was altered i.e. when asymptomatic teeth with deep carious lesions were included . Diagnosis of pulp status is often easy when there is a clear distinction between healthy and necrosed pulp however it is more difficult in asymptomatic teeth with deep carious lesions.

Recently, Coll et al. proposed that glass ionomer cement (GIC) as interim therapeutic restoration (ITR) improved pulpal diagnosis and VPT outcomes while interpreting diagnostic assessment based on clinical pulp therapy success. Vij et al. reported that GIC temporization for 1-3 months increased success of the subsequent VPT from 79% to 92% .However; both of the studies were retrospective and were in deciduous teeth.

No prospective clinical study has so far been conducted in permanent teeth that demonstrate the effectiveness of GIC and other adhesive restoration materials in determining the pulpal status. Aim of this double blinded randomized controlled trial was to assess the effectiveness of GIC interim restoration in determining the pulpal status of asymptomatic teeth with deep carious lesions. Null hypothesis was that GIC as ITR does not improve the clinician's diagnostic ability to determine the correct pulp clinical diagnosis and does not improve the treatment outcomes in vital pulp therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 54 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • mature permanent mandibular molars having deep carious lesions involving half or more of the dentine detected by radiographic examination,
  • pulp sensibility confirmed using the electric pulp test (Digitest D626D; Parkell Electronics, New York, NY) and the cold test (Endo frost, Coltene, Whaledent),
  • absence of apical and furcal radiolucency determined by radiographic examination,
  • absence of clinical symptoms of irreversible symptoms, fistula, swelling and abnormal tooth mobility.
  • Clinical diagnosis of vital pulp was made on the basis of radiographic and clinical examination and the pulp sensibility tests.

排除标准

  • if they presented with signs and symptoms of irreversible pulpitis,
  • had negative response to vitality tests before or after ITR,
  • diabetic, immunocompromised,
  • pregnant,
  • had a positive history of antibiotic use in past one month or required antibiotic prophylaxis.

结局指标

主要结局

clinical success

时间窗: 18 months

Success was defined as absence of signs and symptoms of irreversible pulpitis (spontaneous pain, fistula and swelling), positive response to pulp sensibility tests.

radiographic success

时间窗: 18 months

Absence of periapical alterations (radiolucency at furcal or periapical region, calcification). Pretreatment pulpal diagnosis was considered successful when teeth treated with or without ITR were diagnosed as vital and radiographic signs and symptoms of failure developed.

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

Sanjay Tewari

Principal

Postgraduate Institute of Dental Sciences Rohtak

相似试验