跳至主要内容
临床试验/CTRI/2025/05/086704
CTRI/2025/05/086704尚未招募不适用

Clinical and Radiographic Evaluation of mixture of Endoflas FS powder with Ocimum Sanctum extract and Endoflas FS as an obturating material in primary molars: An In Vivo study.

Dr Kiran Patro1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月31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
40
试验地点
1
主要终点
Clinically and radiographically, mixture of ENDOFLAS-FS’s powder with OCIMUM SANCTUM extract can beused as an obturating material in primary molars.

研究概览

简要总结

Pulpectomy helps to preserve a pulpally involved carious primary tooth by abolishing bacteria and their products and also ensures hermetic seal of the root canals thereby allowing the primary teeth to fulfill its function until normal exfoliation can occur without harming the successor or affecting the health of the individual.Till date, numerous materials such as Zinc oxide eugenol (ZOE), calcium hydroxide, calcium hydroxide with iodoform paste, Guedes-Pinto paste ( a drug combination composed of Iodoform, Rifocort® ointment and Camphorated Paramonochlorophenol (CPC),[6] KRI paste, Maisto’s paste, Walkhoff’s paste, etc. have been tested for their efficiency as root canal filling materials, but none of these have shown to possess all the requisite properties of an ideal root canal filling material for primary teeth, especially with regard to the major desirable property of having a rate of resorption matching that of the physiologic root resorption of the primary teeth.Endoflas (Sanlor & Cia. S. en C.S., Cali, Colombia), a resorbable paste produced in South America, contains similar components as Vitapex, with the addition of zinc-oxide and eugenol. This paste is obtained by mixing a powder containing tri-iodmethane, zincoxide, calcium hydroxide, barium sulfate and iodine dibutilorthocresol with a liquid consisting of eugenol and paramonochlorophenol. There are many advantages of using herbs as antimicrobial agent’s minimal side effects, cost-effective, better patient tolerance, renewable in nature, and non-toxic.[11] One such ancient herb is Ocimum sanctum. It contains 0.7% volatile oil consisting of about 71% eugenol and 20% methyl eugenol.

This is a novel study as no study using mixture of Endoflas FS and Ocimum sanctum as an obturating material has been done till date.

Hence, the current study attempts to replace the higher concentration of Eugenol with a milder concentration using Ocimum sanctum which also has antibacterial, anti-inflammatory effects.

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
3.00 Year(s) 至 9.00 Year(s)(—)
性别
All

入选标准

  • Clinical criteria 1) Children in the age group of 3-9 years of age 2) Restorable primary molars with irreversible pulpitis having clinical signs and symptoms: spontaneous, continous, lingering, and nocturnal pain.
  • Children whose parents give consent for the study Radiographic criteria 1) Atleast 2/3rd of the root present.

排除标准

  • Clinical criteria 1) Children with medical history 2) Children with special health care needs 3) Unrestorable crown portion of the tooth Radiographic criteria 1) Resorption of the root more than 2/3rd of its length 2) External root resorption 3) Internal root resorption 4) Cyst associated with primary molars 5) Primary teeth with vertical fracture.

结局指标

主要结局

Clinically and radiographically, mixture of ENDOFLAS-FS’s powder with OCIMUM SANCTUM extract can beused as an obturating material in primary molars.

时间窗: Evaluation at 1 month, 3 months, and 6 months

次要结局

  • To compare the clinical & radiographic success of the mixture of Endoflas FS powder with Ocimum sanctum extract & Endoflas FS as an obturating material in primary molars.(Evaluation at 1 month, 3 months & 6 months.)

研究者

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

Dr Kiran Patro

Bharati Vidyapeeth (Deemed to be University), Dental College and Hospital, SANGLI

研究点 (1)

Loading locations...

相似试验