跳至主要内容
临床试验/NCT06433297
NCT06433297招募中不适用

Comparative Evaluation of Indirect and Direct Pulp Capping After Partial or Complete Caries Removal in Deeply Carious Mature Permanent Mandibular Molars With Moderate Pulpitis: A Randomized Clinical Trial

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年5月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
106
试验地点
1
主要终点
Clinical Success Rate

研究概览

简要总结

Aim: To compare the outcome of indirect and direct pulp capping after partial or complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

Objectives:

  1. To evaluate the clinical and radiographic success of indirect pulp capping after partial caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
  2. To evaluate the clinical and radiographic success of direct pulp capping after complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
  3. To evaluate pain incidence and severity after indirect and direct pulp capping after partial and complete caries removal in deeply carious mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.

详细描述

Vital pulp therapy has been traditionally recommended only in teeth with reversible pulpitis with no periapical pathologies or in teeth with either mechanical pulp exposure or recent traumatic exposure. Clinical symptoms such as characteristics, severity and intensity of pre-operative pain do not accurately talk about the status of the pulp inflammation and the depth of involvement. It has been demonstrated that there is no precise correlation between clinical symptoms and the histopathological status of the pulp, mainly in case of irreversible pulpitis, that might lead to a wrong diagnosis. Vitality tests such as cold test or electric pulp tests reveal only whether the pulp is responsive to respective stimuli or not. According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which corresponds to irreversible pulpitis. Vital pulp therapy is suggested to be the choice of treatment for such cases. It has been suggested that infection is often a cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Partial caries removal, which involves complete removal of carious dentine from the surrounding cavity walls, followed by the partial removal of infected dentin at the pulpal wall which reduce chances of pulp exposure followed by placement of medicament for Indirect pulp capping. Whereas during Complete caries removal, caries is completely removed from surrounding walls as well as on pulpal wall which increase the chances of pulp exposure followed by placement of medicament for Direct pulp capping procedure. Based on this premise, IPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of direct pulp capping, partial pulpotomy or full pulpotomy in adults.

Research Question Does Indirect Pulp Capping have comparable outcome with Direct pulp capping after partial caries removal in deeply carious mature permanent molars with clinical signs indicative of moderate pulpitis? P (Population) - Deeply carious mature Permanent Mandibular molars with clinical signs indicative of moderate pulpitis I (Intervention) - Partial caries removal followed by Indirect pulp capping C (Comparison) - Complete caries removal followed by Direct pulp capping O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.

  • To assess incidence and reduction in pain post operatively at every 24 hours till 1 week.

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 (Participant)

盲法说明

Considering the nature of intervention, masking of the operator will not be possible once he begins the caries removal. Patients will be unaware of the groups in which their allocation will take place. At the time of assessing data masking will be done by masking the entire crown of the tooth before evaluation by endodontist using Adobe Photoshop CS6.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patient should be ≥18 years of age.
  • Restorable mature permanent 1st and 2nd Mandibular molars with deep caries (reaching inner quarter of dentine)
  • Tooth should give positive response to pulp sensibility testing.
  • Clinical diagnosis of moderate pulpitis.
  • Radiographic finding of periapical index (PAI) score ≤
  • Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).
  • Pulp exposure after complete caries excavation.
  • No pulp exposure after incomplete caries excavation

排除标准

  • Teeth with immature roots.
  • Pulp exposure after incomplete caries excavation.
  • No pulp exposure after complete caries excavation.
  • Bleeding could not be controlled in 5 minutes.
  • Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
  • History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
  • Internal/external resorption.
  • Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine)

研究组 & 干预措施

Partial caries removal followed by Indirect pulp capping.

Experimental

Partial caries removal followed by Indirect pulp capping.

干预措施: INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS (Procedure)

Complete caries removal followed by Direct Pulp Capping

Active Comparator

Complete caries removal followed by Direct Pulp Capping

干预措施: INDIRECT AND DIRECT PULP CAPPING AFTER PARTIAL OR COMPLETE CARIES REMOVAL IN DEEPLY CARIOUS MATURE PERMANENT MANDIBULAR MOLARS WITH MODERATE PULPITIS (Procedure)

结局指标

主要结局

Clinical Success Rate

时间窗: 12 months

No pain or discomfort. No tenderness to palpation or percussion. Normal mobility and probing pocket depth.

Radiographic success

时间窗: 12 months

No pathology on the radiograph.

次要结局

  • Pain reduction(Seven days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Comparative Evaluation of Indirect vs. Direct Pulp... | 临床试验