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临床试验/CTRI/2025/01/079343
CTRI/2025/01/079343已完成3 期

Outcome of direct pulp capping With Premixed Bioceramic Material And Mineral Trioxide Aggregate In Mature Permanent Molars With Pulps Exposed During Carious Tissue Removal: A Randomized Clinical Trial

Dr Sachin Sunil Sawant1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年2月2日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
To evaluate and compare the treatment outcome of direct pulp capping using Premixed bioceramic material or Mineral Trioxide Aggregate clinically and radiographically at 1 week, 3 months and 6 months

研究概览

简要总结

In our day-to-day clinical practice most of the patients walk into our clinic with deep or extremely deep carious lesions. To ensure a line of treatment which has always been successful, dentists intervene by doing root canal treatment because of its high success rate. However after delivery of root canal treatment the vitality of the pulp is lost. The vitality of the pulp is essential to Preserve the defense mechanism of the pulp Enable dentin formation, Enhancement of the Survival rate- Vital Teeth > Endodontically treated teeth, Avoid root fracture. Because of this, we are mindful in excavating, deep, extremely deep carious lesions, because today there is a concept of selective caries excavation which advices removal of infected dentine and keeping the affected dentine in place and packing it with pulp capping material which is known as Indirect Pulp Capping. However, AAE , very firmly in there position statement have said hard or firm dentin and dentin below white spot enamel lesions is infected by bacteria in both active and arrested lesions. Histobacteriological studies have consistently shown the presence of chronic inflammatory cell infiltrates and subclinical pulp inflammation where carious tissues are retained, thus potentially compromising pulp vitality. Keeping this school of thought in effect, when caries are very deep we may adverently expose the pulp during the removal of caries itself. We have a Position Statement by our very own Indian Endodontic Society published in the year 2022 which states that **Direct Pulp Capping(DPC)**is considered the most conservative and simplest of the VITAL PULP THERAPIES. It involves applying a biomaterial directly onto the exposed pulp before immediately placing a permanent restoration under aseptic conditions. A randomized clinical trial provides the highest level of support for evidence based clinical practice. There have not been many randomized clinical trials conducted for comparing the outcomes of Premixed Bioceramic Material and Mineral Trioxide Aggregate in mature permanent molars with pulps exposed during carious tissue removal. As DPC is mostly a onevisit procedure, conservative, costeffective, preserving pulp vitality, immunological and proprioceptive function of dental pulp while delaying the restorative cycle, and is considered an ideal treatment option for India where the oral disease burden is high. Thus, there is a need for a randomized clinical trial to evaluate and compare the Treatment outcome of Direct Pulp Capping using the new Premixed Bioceramic Material and comparing it with Mineral Trioxide Aggregate which is advocated for direct pulp capping procedures today.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
16.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Pre-Caries Excavation inclusion criteria A Permanent maxillary and mandibular first and second molars with large carious lesions involving either occlusal or proximal surfaces B Radiographic examination revealing carious lesions in close proximity to the pulp C Teeth with history of pain of short duration, caused by a specific irritant and disappearing when irritant is removed D Patients with non-contributory medical history, good general health E Patients ranging in the age group of 16-40 years F Teeth with adequate coronal structure to ascertain proper isolation Post-Caries excavation inclusion criteria 1 Pulp Exposures less than 1mm 2 Teeth which achieved haemostasis within 10 minutes 3 Non contaminated operating field.

排除标准

  • PATIENT SPECIFIC
  • Patients who refuse to consent for the procedure
  • Patients with any systemic diseases, pregnancy or immuno-compromised conditions
  • Patients allergic to lignocaine or any other material used in the trial B SPECIFIC TO DIAGNOSIS
  • Teeth presenting a negative cold thermal test and a prolonged or no response to electric pulp testing
  • Teeth with symptoms and signs of irreversible pulpitis
  • Teeth exhibiting periapical radiolucencies on radiographic examination
  • Teeth with internal or external resorption
  • Teeth showing positive responses to percussion or palpation
  • Retreatment cases
  • Teeth with aggressive periodontitis or mobility TOOTH SPECIFIC 1 Teeth showing persistent pulpal hemorrhage after receiving 10 minutes of sodium hypochlorite dressing during the pulp capping procedure 2 Teeth with greater than1mm of pulpal exposure 3 Teeth which have been managed by Indirect Pulp Capping Procedure.

结局指标

主要结局

To evaluate and compare the treatment outcome of direct pulp capping using Premixed bioceramic material or Mineral Trioxide Aggregate clinically and radiographically at 1 week, 3 months and 6 months

时间窗: 1 week, 3 months and 6 months intervals.

次要结局

  • To compare the association of variables namely age, sex and caries location between the groups.

研究者

发起方
Dr Sachin Sunil Sawant
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sachin Sunil Sawant

Kaher KLE VIshwanath Katti Institute Of Dental Sciences

研究点 (1)

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