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临床试验/CTRI/2019/06/019908
CTRI/2019/06/019908尚未招募3 期

Clinical and Radiographic Outcomes of Three Root Canal Obturating Materials for Pulpectomy in Primary Mandibular Molars: A Double Blinded Randomized Controlled Trial.

Pragyna Priyadarshini1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2019年8月7日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
84
试验地点
1
主要终点
Furcation/periapical radiolucency

研究概览

简要总结

The primary objective of pulpal treatment is to preserve the integrityand health of the oral tissues. Endodontics in primary teeth is evenmore challenging because of the anatomic complexities, dynamic alterationat the root apex and close proximity to the succedaneous tooth bud. In thiscontext root canal filling materials assume added importance, which must beresorbable, anti-bacterial and biocompatible in nature. Zinc oxide eugenol(ZOE) is the most widely used obturating material in primary teeth despite itsfew drawbacks such as delayed resorption when extruded beyond the apex,deflection in position of underlying successor tooth and its toxicity inperiradicular tissues. Thus to overcome such drawbacks, various obturatingmaterials and herbal derivatives have been introduced for pulpal treatment inchildren.

Turmeric (CurcuminLonga) is a medicinal herb and has been tested clinically for its antioxidant,antiinflammatory and antimicrobial properties which can be effectively used asan obturating material in primary teeth. The rationale behind the use of Curcumingel with Endoflas powder is to overcome the disadvantages of Endoflas-eugenolmix.

Thus the present study is undertaken to evaluate the clinical andradiographic outcomes of Endoflas, Endoflas powder with Curcumin gel andPulpdent root canal sealer (ZOE) as obturating materials in primary mandibularmolars.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
4.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Carious/deeply carious teeth with intra/extra-oral swelling/draining sinus tract Abnormal mobility Spontaneous pain with tender on percussion Continuous bleeding on amputation of coronal pulp Furcation/periapical radiolucency Internal root resorption involving only cervical 1/3rd of root External root resorption involving 1/3rd or less than 1/3rd of root length.

排除标准

  • Children with systemic pathosis/special care needs Untoward reaction to LA or to ingredients of test materials Teeth not restorable/perforated pulpal floor.

结局指标

主要结局

Furcation/periapical radiolucency

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

CLINICAL OUTCOMES :

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

Pain

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

Tenderness to percussion

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

Swelling/Abscess

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

Mobility

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

Draining fistula

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

RADIOGRAPHIC OUTCOMES :

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

Internal/External root resorption

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

Continuity of lamina dura

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

Deviation in path of eruption of succeedaneous tooth

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

Intra-radicular resorption

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

Resorption of extruded material

时间窗: 1 week | 1 month | 3 months | 6 months | 9 months | 12 months

次要结局

未报告次要终点

研究者

发起方
Pragyna Priyadarshini
申办方类型
Other [Self funded]

研究点 (1)

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