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临床试验/CTRI/2025/02/080136
CTRI/2025/02/080136尚未招募3 期

A Comparative clinico-radiographic evaluation of efficacy of different pulpotomy agents used in Primary molars - A Randomised Controlled Trial

Dr Akanksha Sirohi1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年2月15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
64
试验地点
1
主要终点
Evaluate Occasional pain, Sensitivity (TOP), Fistula, Pathological mobility; Radiolucency at furcation, Internal/ external resorption, and Calcification in pulpotomised tooth.

研究概览

简要总结

Preserving primary teeth is a key goal in pediatric dentistry, especially in the context of Early Childhood Caries (ECC) and Traumatic Dental Injuries (TDI), both of which are prevalent globally, including in India. ECC affects 49.6% of children in India, while TDI occurs in 13% of children, with higher rates in those under 6 years old. If untreated, both conditions can lead to early pulp exposure, necessitating costly and complex treatments like endodontic therapy.

To manage pulp exposure, techniques like pulpotomy are commonly used. Pulpotomy involves removing the coronal pulp to preserve the vitality of the root portion, typically in cases of extensive caries or trauma without radicular pathology. Over the years, various materials have been used for pulpotomy, including formocresol, zinc oxide eugenol (ZOE), mineral trioxide aggregate (MTA), biodentine (BD), enamel matrix derivative (Emdogain), and laser therapy.

Formocresol was historically used but is no longer recommended due to its toxicity. Alternatives like MTA and BD are popular due to their biocompatibility, sealing ability, and favorable clinical outcomes. BD, in particular, offers advantages like quick setting time and ease of handling over MTA. Emdogain, a newer material, shows promise in regenerating tooth tissues and enhancing periodontal attachment, though research is limited.

Lasers, specifically diode lasers, are also being explored for pulpotomy, as they allow precise tissue removal with minimal impact on surrounding dental structures. Despite the variety of materials and techniques, few studies have directly compared their clinical and radiographic success, making this area an important focus for future research.

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, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • Cooperative healthy pediatric patient aged 4-10 years
  • Presence of carious primary molar/ traumatic exposure / mechanical exposure during caries excavation
  • Restorable crown structure present
  • Presence of atleast 2/3rd root length
  • Bright red hemorrhage from exposure sites that can be controlled during pulpotomy procedure
  • No interradicular bone loss and radiolucency.

排除标准

  • Uncooperative patient
  • Medically compromised children
  • Teeth with clinical sign and symptoms of pulpal exposure with persistent pain
  • Primary teeth with root resorption more than 2/3rd of the root length
  • A non restorable teeth
  • Teeth with radiographic sign and symptoms of pulp degeneration, pathologic mobility, swelling or/and fistula, external or internal resorption and calcification of pulp.

结局指标

主要结局

Evaluate Occasional pain, Sensitivity (TOP), Fistula, Pathological mobility; Radiolucency at furcation, Internal/ external resorption, and Calcification in pulpotomised tooth.

时间窗: 12 months

次要结局

  • Evaluate Occasional pain, Sensitivity (TOP), Fistula, Pathological mobility; Radiolucency at furcation, Internal/ external resorption, and Calcification in pulpotomised tooth.(3, 6, 9 months)

研究者

发起方
Dr Akanksha Sirohi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Akanksha Sirohi

Subharti dental college and hospital

研究点 (1)

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