跳至主要内容
临床试验/CTRI/2025/07/090099
CTRI/2025/07/090099尚未招募4 期

Comparative evaluation of laser activated collagen and Light cure MTA as a novel pulpotomy agent: A randomized control trial

Kashyap B1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
44
试验地点
1
主要终点
To compare the clinical and radiographic success of Laser-Enhanced Collagen and Light-Cured MTA pulpotomy procedures at specified follow-up intervals.

研究概览

简要总结

After the selection of participants, the procedure will begin with administration of local anesthesia and the teeth will be isolated. The soft carious lesions will be first excavated using a spoon excavator, followed by which access opening will be performed using a high-speed bur with the aerator. Following the initial drop into the pulp chamber, the tooth will be reassured by operative diagnosis by analyzing the nature of the pulpal bleeding. Following the Satisfactory operatory diagnosis, the treatment will be continued, the pulp chamber will be completely deroofed, the coronal portion of the pulp will be removed with the intact untouched radicular pulp, and finally, irrigation will be done with saline to remove the dentinal debris. A cotton pellet dipped with saline will be placed over the root canal orifice to attain hemostasis, followed by which Light cure MTA pulpotomy and Laser enhanced collagen-based pulpotomy will be carried in their respective groups. After the pulpotomy procedures the tooth will be restored with the Stainless steel crowns.

Follow up will be done at 1 month, 3 month, 6 months and 12 months. At each time period clinical (pain, tenderness to percussion, abscess, swelling, fistula, and pathologic mobility) and radiographic analysis(radicular radiolucency, internal and external root resorption, periodontal ligament space widening, and furcation radiolucency) will be made.

研究设计

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

入排标准

年龄范围
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • An age range of 4-8 years,Lower right/left first/ second primary molars with reversible pulpitis, Carious/mechanical pulp exposure, No clinical or radiographic sign of pulp pathoses, Deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.

排除标准

  • History of spontaneous and unprovoked pain, Mobility, Sensitive to percussion, Any sign of Presence of fistulae, external or internal root resorption, carious furcation involvement, and periapical lesion, Dystrophic calcification of the pulp.

结局指标

主要结局

To compare the clinical and radiographic success of Laser-Enhanced Collagen and Light-Cured MTA pulpotomy procedures at specified follow-up intervals.

时间窗: at 1 month, 3 months, 6 months, 12 months

次要结局

未报告次要终点

研究者

发起方
Kashyap B
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Kashyap B

AME Dental College Raichur,Karnataka,India

研究点 (1)

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