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临床试验/CTRI/2025/06/089611
CTRI/2025/06/089611尚未招募4 期

Comparative clinical and radiographical evaluation of Pulpectomies using obturating material with and without neem Gel in primary molars: split-mouth randomized controlled trial

Shreya Avinash Puri1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月7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
30
试验地点
1
主要终点
Clinical and radiographical evaluation of Endoflas with neem gel and Endoflas as obturating materials in primary molars.

研究概览

简要总结

Title: COMPARATIVE CLINICAL AND RADIOGRAPHICAL EVALUATION OF PULPECTOMIES USING OBTURATING MATERIAL WITH AND WITHOUT NEEM GEL IN PRIMARY MOLARS: SPLIT-MOUTH RANDOMIZED CONTROLLED TRIAL

Preservation of the primary tooth in its healthy state should be the goal of every pediatric dentist. Primary teeth are considered the best space maintainers hence, they should be retained for a longer duration to maintain their functions. Reversible pulpitis in primary teeth is treated with vital pulp therapy. Pulpectomy is one of the preferred treatment modalities indicated in teeth with pulpal necrosis, chronic pulpitis, and accidental exposure of the pulp. It is a more conservative approach to prevent the premature loss of primary teeth. The success of the pulpectomy depends on adequate access, cleaning and shaping, and good quality obturation. In deciduous teeth, materials having antimicrobial, resorbability, noninflammatory and nonirritating, and radiopacity for visualization on radiograph qualities are widely utilized as root canal filling materials to increase the likelihood that the endodontic treatment will be successful.

Endoflas is a material that encompasses the desirable properties of  zinc oxide eugenol, calcium hydroxide, and iodoform. It is hydrophilic, firmly adheres to the surface of the root canal walls, and has the ability to disinfect the dentinal tubule. Endoflas is associated with certain disadvantages, like periapical irritation and tooth discoloration, due to the presence of eugenol as a component.

To overcome these disadvantages of the currently available primary root canal obturating materials, there is a continued interest in the search for chemical compounds with broader and more effective antibacterial action and less cytotoxicity.

Herbal products are gaining popularity in dentistry due to their biocompatibility, higher antimicrobial activity, and antioxidant and anti-inflammatory properties.

One such ancient herb that has received enormous scientific attention is Azadirachta indicia A. Juss (A. indica), commonly known as Neem, which has attracted worldwide importance in recent years. It has a wide range of medicinal properties, like, anti-bacterial, anti-fungal, anti-viral, anti-oxidant, anti-ulcer, and anti-inflammatory.

Therefore, this current study is designed to compare the clinical and radiographic success of Endoflas with neem gel and Endoflas as an obturating material in primary molars.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
3.00 Year(s) 至 8.00 Year(s)(—)
性别
Female

入选标准

  • Young cooperative patients aged 3–8 years.
  • Children with complaints of pain in pulpally involving primary molars.
  • Primary molars having a minimum of 2/3rd of remaining root length.
  • Restorable tooth structure.

排除标准

  • Children with special healthcare needs or systemic diseases.
  • Presence of internal or external root resorption.
  • Increased mobility other than physiological mobility.

结局指标

主要结局

Clinical and radiographical evaluation of Endoflas with neem gel and Endoflas as obturating materials in primary molars.

时间窗: 12 Months

次要结局

  • Compare the quality of obturation using Endoflas with neem gel and Endoflas as obturating materials in primary molars.

研究者

发起方
Shreya Avinash Puri
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mahesh Dadpe

Maharashtra Institute of Dental Sciences and Research dental college Latur

研究点 (1)

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