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临床试验/CTRI/2025/03/082956
CTRI/2025/03/082956尚未招募4 期

Comparative evaluation of N-acetyl cysteine and Mineral trioxide aggregate (MTA) as pulpotomy medicaments in primary molars: A 12-month follow-up randomized clinical trial

Sanket Vijay Parmalkar1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月31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
50
试验地点
1
主要终点
N acetyl cysteine will show better or equal results as compared to MTA when used as a pulpotomy agent

研究概览

简要总结

Pulpotomy is widely used for treatment of primary tooth to maintain its integrity until normal exfoliation. An ideal pulpotomy material should have appropriate sealing ability, bio-inductivity, biocompatibility, and have the ability to eliminate bacteria and preserve healthy radicular pulp and promote its healing. However, none of the available and recommended medicaments for pulp therapy present all these properties.Although Formocresol (FC) has long been considered to be the gold standard, researchers are questioning its use in pulpotomy because of possible mutagenic and toxic effects. Different materials such as calcium hydroxide, ferric sulfate, and glutaraldehyde have been suggested as an alternative for FC.Numerous medicaments with various protocols that retain radicular pulp vitality from time to time since the success of pulpotomy relies on medicament used. Owing to intricacies of earlier medicaments, the thrive for better drug made clinicians eye toward regenerative materials in the recent past. Mineral trioxide aggregate (MTA) is one such regenerative material recognized as the reference material for conservative pulp vitality treatments in primary teeth, with high pulpotomy success rates (90%–100%) in clinical, radiographic, and histopathologic studies.

 N-acetylcysteine (NAC) is a membrane-permeable aminothiol compound with diverse functions. NAC is shown to be the precursor of GSH with a significant antioxidant effect.NAC has also been regarded as an anti-inflammatory compound. Therefore, NAC is shown to have a number of different functions depending on the nature of the cells and their stage of maturation. However, it seems one of the primary functions of NAC is inhibition of cell death. At present it is unclear how NAC protects the cells from cell death. However, previous work has attributed the protective effect of NAC in HEMA- and TEGDMA-mediated cell death to its antioxidant effects.

 Few studies have reported that the n acetyl l cysteine inhibits cell death due to its antioxidant effect. No study have been reported which uses N acetyl l cysteine as pulpotomy agent in primary teeth. The motivation behind the study is to evaluate the efficacy of N acetyl l cysteine when used for pulpotomy of primary teeth.Thus this randomised clinical study will be used to evaluate the efficacy of N acetyl l cysteine in pulpotomy of primary molars, among children aged between 5-12 yrs.

The study is based on the hypopthesis that both the N acetyl l cysteine can be used as an alternative material in pulpotomy of primary teeth.

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
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • patient aged 5-12 years, Deep Carious/mechenical exposure in vital asymptomatic tooth, Tooth free of radicular pulpitis, Presence of atleast 2/3rd of root length.

排除标准

  • Presence of absecess,fistula or swelling, Presence of interradicular bone loss, Presence of internal root resorption, Presence of necroyic pulp, Tooth close to natural exfoliation, Mobility of tooth, Pain on percussion.

结局指标

主要结局

N acetyl cysteine will show better or equal results as compared to MTA when used as a pulpotomy agent

时间窗: Evaluation will be done at 3 months, 6 months and 12 months respectively

次要结局

  • N acetyl cysteine preserves the vitality of remaining radicular pulp, prevents root resorption and has better bactericidal effect as compared to MTA(Evaluation will be done at 3 months, 6 months and 12 months respectively)

研究者

发起方
Sanket Vijay Parmalkar
申办方类型
Other [[self]]
责任方
Principal Investigator
主要研究者

Sanket Vijay Parmalkar

Pacific Dental College and Hosptial Debari Udaipur

研究点 (1)

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