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临床试验/CTRI/2025/03/082555
CTRI/2025/03/082555尚未招募2 期

Comparative Evaluation of Selective Caries Removal and Partial Pulpotomy Performed For Management of Extremely Deep Carious Lesion With Non-Spontaneous Symptomatic Pulpitis In Mature Permanent Teeth: A Randomized Clinical Trial

Dr Pranav Kagane1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年3月28日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
56
试验地点
1
主要终点
To assess the outcome of mature permanent teeth with extremely deep carious

研究概览

简要总结

The study is a randomized control trial with parallel study design for managing deep and extremely deep tooth decay in mature teeth, where the pulp may be at risk. It compares two treatment methods: selective caries removal, a minimally invasive approach that preserves more of the tooth and reduces pulp risks, and pulpotomy, a more invasive procedure that involves removing part of the pulp but carries higher risks. The study highlights the need for a clinical trial to determine the best approach for treating extremely deep caries while protecting the pulp. with patient follow up at 3, 6, and 122 months

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Healthy patients of either gender belonging to 18 to 40 age with mature permanent maxillary and mandibular molar teeth • Teeth with extremely deep carious lesions i.e. carious lesion penetrating the entire thickness of the dentin, without a radio-dense zone.
  • • Teeth with established clinical diagnosis of nonspontaneous symptomatic pulpitis (initial and mild pulpitis) • Teeth with positive response to cold and electric pulp test.

排除标准

  • Deep carious lesions extending ≥3/4 of the dentine thickness, with a visible radiopaque zone separating the carious lesion from the pulp, of mature permanent teeth with spontaneous symptomatic irreversible pulpitis • Extremely deep carious lesion with periapical rarefaction.
  • • Teeth with clinical diagnosis of spontaneous symptomatic pulpitis (Moderate and severe pulpitis) • Teeth with cracks, cusp fractures, subgingival caries and poor periodontal health • Patients with systemic conditions which could compromise the healing.
  • • Patients not willing to participate in the study.

结局指标

主要结局

To assess the outcome of mature permanent teeth with extremely deep carious

时间窗: 3,6,12 months

lesion and non-spontaneous symptomatic pulpitis managed by

时间窗: 3,6,12 months

a. Indirect pulp capping with selective caries removal

时间窗: 3,6,12 months

b. Partial Pulpotomy

时间窗: 3,6,12 months

次要结局

  • To compare the outcome of Indirect pulp capping with selective caries(removal and partial pulpotomy with hydraulic calcium silicate cement for)

研究者

发起方
Dr Pranav Kagane
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Pranav Kagane

center for dental education and research , AIIMS , new delhi

研究点 (1)

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