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临床试验/CTRI/2026/03/105905
CTRI/2026/03/105905尚未招募不适用

Comparative evaluation of Zinc oxide-Ozonated oil and Endoflas as root canal filling materials in primary molars: an in-vivo study

SMBT Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2026年3月23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
68
试验地点
1

研究概览

简要总结

This study will be conducted to evaluate and compare the clinical and radiographic outcomes of two root canal filling materials, zinc oxide–ozonated oil and Endoflas, in pulpectomy procedures performed in primary molars. Pulpectomy is commonly indicated in primary teeth with irreversible pulpitis or necrotic pulp; however, the ideal obturating material should possess antimicrobial properties, biocompatibility, and the ability to resorb in harmony with the physiological root resorption of primary teeth.

In this randomized clinical trial, children requiring pulpectomy in primary molars will be recruited and randomly allocated into two groups. Following standard biomechanical preparation of the root canals, the canals will be obturated with either zinc oxide–ozonated oil or Endoflas according to the assigned group.

The treated teeth will be evaluated for clinical and radiographic success at predetermined follow-up intervals of 3, 6, and 9 months. Clinical parameters such as pain, swelling, sinus tract, abnormal mobility, and tenderness to percussion will be assessed, while radiographic evaluation will include assessment of periapical or furcation radiolucency, pathological root resorption, and signs of healing.

The findings of this study will help determine whether zinc oxide–ozonated oil can serve as an effective alternative to Endoflas as an obturating material in pulpectomy of primary molars.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Children in the age group of 4-8 years Children with primary molars showing signs and symptoms of irreversible pulpitis or necrosis (with or without periradicular infection, extraoral or intraoral swelling, sinus opening, grade I mobility) Primary molars having more than 2/3rd of root remaining Children whose parents will give consent for the study.

排除标准

  • Non-restorable primary molar Primary molar with mechanical or carious perforation of the floor of pulp chamber Presence of radicular cyst Primary molars exhibiting greater than grade I mobility Traumatized teeth with vertical fracture26 Presence of pathologic internal or external root resorption Children who have significant medical history Specially-abled children Children who will be participating in another clinical trial.

研究者

发起方
SMBT Dental College and Hospital
申办方类型
Other [Private dental college and hospital.]
责任方
Principal Investigator
主要研究者

Dr Vinaya Kumar Kulkarni

SMBT Dental College and Hospital, Sangamner

研究点 (1)

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