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临床试验/CTRI/2023/11/059915
CTRI/2023/11/059915已完成4 期

Evaluation of the Efficacy of Indirect Pulp Therapy with Selective Removal of Carious Dentin in Permanent Teeth: An in Vivo Study with One Year Follow Up

SGT UNIVERSITY1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年1月12日最近更新:

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
1
主要终点
Tooth is vital

研究概览

简要总结

AIM: Evaluation of the Efficacy of Indirect Pulp Therapy with Selective Removal of Carious Dentin in Permanent Teeth.

OBJECTIVE: To evaluate the remineralization in permanent teeth with selective removal of carious dentin using calcium hydroxide as a liner and to access pulp vitality after selective removal of carious dentin in permanent teeth with deep carious lesion.

METHODOLOGY: 100patients diagnosed with asymptomatic reversible pulpitis will be selected. Infected carious dentin will be removed using round diamond bur. After superficial necrotic dentin is removed, spoon excavator will be used for excavation of soft carious dentin. Infected dentin will be completely removed from lateral walls leaving thin layer of soft carious tissue over pulp to avoid exposure. A thin layer of calcium hydroxide liner will be applied on cavity floor followed by a base of colored composite. The cavity will be restored with composite resin.

Clinical follow up examination for post op sensitivity, pain, tenderness, vitality and radiographic examination was performed at 1month,6months and 12months.Criteria for successful outcome involves formation of hard tissue, positive sensibility tests, no pain on percussion and no clinical or radiographical signs and symptoms of irreversible pulpitis

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
25.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Deeply carious tooth with proximity of lesion extending into pulpal third or quarter of the dentine as confirmed by the radiograph (score 4).

排除标准

  • Immunocompromised patients.
  • Association of periapical lesion or widening of periodontal space visible on radiograph.
  • Presence of internal or external root resorption.
  • Teeth with pulp exposure.

结局指标

主要结局

Tooth is vital

时间窗: At 1year follow up

次要结局

  • Tooth is vital & asymptomatic(At 1 & 6 months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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