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临床试验/CTRI/2025/05/087046
CTRI/2025/05/087046尚未招募2 期

Clinical and radiographic evaluation of a mixture of zinc oxide nanohydroxyapatite powder with aloevera gel metapex and endoflas as obturating material in primary molars A randomized controlled study

Dr Muppa Susmitha1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年7月30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
84
试验地点
1
主要终点
To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars.

研究概览

简要总结

Preservation of primary teeth is essential as they guide the permanent teeth, maintaining arch length and function. Endodontic treatment, specifically pulpectomy, is crucial for primary teeth with infected and necrotic pulp. Chemomechanical therapy alone often fails to disinfect all bacteria, necessitating a filling paste that is antibacterial, biocompatible, radiopaque, adheres to canal walls without voids, resorbable if it goes beyond the apex, easily removable when needed.  

AIM OF THE STUDY The aim of the study is to evaluate the clinical and radiographic success rate of a mixture of Zinc oxide-nanohydroxyapatite powder with aloevera gel, Metapex, and Endoflas as obturating material in primary molars.

OBJECTIVES OF THE STUDY

1)To clinically and radiographically evaluate the success rate of a mixture of Zinc oxide-nanohydroxyapatite powder with aloevera gel as an obturating material in primary molars.

2)To clinically and radiographically evaluate the success rate of Metapex as obturating material in primary molars.

3)To clinically and radiographically evaluate the success rate of Endoflas as obturating material in primary molars.

4)To compare clinical and radiographic success rates of a mixture of Zinc oxide nanohydroxyapatite powder with alovera gel, Metapex, and Endoflas as obturating material in primary molars.

Group I– Metapex. Group II – Endoflas. Group III– Mixture of zinc oxide-nano hydroxyapatite powder with aloevera gel.

Post endodontic restoration with type - II Glass ionomer cement will be done followed by the placement of semi-permanent crowns after 1 month. Clinical evaluation will be done for pain, tenderness on percussion, gingival swelling or inflammation, mobility, presence of fistula or sinus opening. A postoperative digital radiograph will be taken for assessment of the obturation quality and will be categorized as underfilled, optimal filled, or overfilled canals, furcation or periapical radiolucency, extensive pathological root resorption. Both clinical and radiographic evaluation of the pulpectomy treated teeth will be carried out at 3, 6, and 9 months respectively.

研究设计

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

入排标准

年龄范围
6.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • History of spontaneous pain Primary molars with caries involving the pulp Presence of atleast 2/3rd of root length Presence of inter/periapical radiolucency Tooth that cannot be restorable.

排除标准

  • Children with any underlying systemic diseases Preshedding and abnormal pathologic mobility Any sinus opening or fistula In case of internal or external resorption Extensive inter/periapical radiolucency Tooth that cannot be restorable.

结局指标

主要结局

To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars.

时间窗: To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars. | To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars at three six nine months

To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars.

时间窗: To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars. | To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars at three six nine months

To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars.

时间窗: To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars. | To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars at three six nine months

To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars.

时间窗: To clinically and radiographically evaluate the success rate of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Metapex as an obturating material in primary molars. | To clinically and radiographically evaluate the success rate of Endoflas as an obturating material in primary molars. | To compare clinical and radiographic success rates of a mixture of zinc oxide-nanohydroxyapatite powder with aloe vera gel, Metapex, and Endoflas as obturating material in primary molars at three six nine months

次要结局

未报告次要终点

研究者

发起方
Dr Muppa Susmitha
申办方类型
Other [nil]

研究点 (1)

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