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临床试验/CTRI/2025/09/095428
CTRI/2025/09/095428尚未招募不适用

Clinical and Radiographic Assessment of Pulpotomy in Diabetic and Non Diabetic individuals with Symptomatic Pulpitis A Randomized Clinical Trial

Kodipyaka Sushmitha1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
CLINICAL OUTCOMES:

研究概览

简要总结

This randomized clinical trial aims to evaluate and compare the clinical and radiographic outcomes of pulpotomy procedures in controlled diabetic and nondiabetic individuals diagnosed with symptomatic irreversible pulpitis. Participants will be allocated into two parallel groups (diabetic and nondiabetic) and will undergo a standardized pulpotomy treatment using biocompatible materials. Clinical parameters such as pain tenderness mobility along with radiographic findings ( periapical status,internal or extrnal resorption,hard tissue barrier formation), will be assessed at baseline 1month 3 months 6 months and 12 months post-treatment. The study seeks to determine whether systemic diabetic status influences the healing outcome and success of pulpotomy treatment in mature permanent teeth.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • Healthy and controlled diabetics with HbA1c value (5.7 to 7) Premolars and molars diagnosed with symptomatic pulpitis Presence of large carious lesions radiographically Moderate to severe pain with positive pulp sensibility tests Vital pulp tissue visible upon accessing the pulp chamber Hemostasis achieved within 10 minutes after pulpotomy.

排除标准

  • Patients with ASA III,IV,V,VI 2) Pregnant women 3) Necrotic pulp or non-vital teeth 4)Teeth with periapical lesions 5)Presence of internal or external tooth resorption Failure to control bleeding within 10 minutes of the procedure.

结局指标

主要结局

CLINICAL OUTCOMES:

时间窗: 24hours 1week 12weeks 24weeks 48weeks

1 Absence of signs and symptoms of symptomatic pulpitis

时间窗: 24hours 1week 12weeks 24weeks 48weeks

2 absence of swelling or sinus tract

时间窗: 24hours 1week 12weeks 24weeks 48weeks

3 Absence of abnormal tooth mobility

时间窗: 24hours 1week 12weeks 24weeks 48weeks

RADIOGRAPHIC OUTCOMES

时间窗: 24hours 1week 12weeks 24weeks 48weeks

1 No sign of internal or external root resorption

时间窗: 24hours 1week 12weeks 24weeks 48weeks

2 No new periapical pathosis

时间窗: 24hours 1week 12weeks 24weeks 48weeks

3 Formation of hard tissue barrier

时间窗: 24hours 1week 12weeks 24weeks 48weeks

次要结局

未报告次要终点

研究者

发起方
Kodipyaka Sushmitha
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Kodipyaka Sushmitha

MNR Dental College and Hospital

研究点 (1)

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