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临床试验/CTRI/2026/01/101519
CTRI/2026/01/101519尚未招募3 期

A Randomized Controlled Clinical Trail to Evaluate the Efficacy Of Pippali Churna Pratisarana in Children with Delayed Dentition

Dr Snehal Bhausaheb Bargal1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月31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
40
试验地点
1

研究概览

简要总结

Delayed dentition represents a significant developmental concern in pediatric healthcare, with normal tooth eruption typically beginning around 6-8 months of age. Delayed eruption is usually considered when there are no teeth by approximately 13months of age.

Dental development includes mineralization, eruption, and exfoliation Initial mineralization begins as early as the 2nd trimester (mean age for central incisors, 14 wk) and continues through 3 yr of age for the primary (deciduous) teeth and 25 yr of age for the permanent teeth. Mineralization begins at the crown and progresses toward the root. Eruption begins with the central incisors and progresses laterally. Exfoliation begins at about 6 yr of age and continues through 12 yr of age.1

Deciduous teeth start to erupt at the age of 6 months, and the deciduous dentition is completed by the age of approximately  2 years.2

The prevalence of delayed dentition is 5-10% and varies globally, with multiple contributing factors including genetic predisposition, nutritional deficiencies, premature birth, low birth weight, and systemic conditions.

As per Ayurveda, Teeth (Danta) are Updhatu (a by-product of) Asthi, it has a    predominance of Prithvi (earth element) and Vayu (air element) Mahabhuta. The word Ruchakasthi describes a specific type of bone called Teeth (Dantas).3

Aacharya Kashyapa considers teeth as an index of good health. A tooth is an indication of age and health. Dentistry has gained more recognition because of its cosmetic value. The emergence of 1st tooth in an infant is considered as an important milestone.

A tooth has predominance of Prithvi and Vayu Mahabhuta. Aacharya Sharangdhara considered teeth as Updhatu of Asthi Dhatu. Teeth are also called as Ruchakas.4

Body weight and height are commonly used to evaluate the developmental and nutritional status of infants. In addition, the eruption time of primary teeth, i.e., deciduous teeth, such as primary central incisors and primary lateral incisors, is a visible indicator of infant physical growth other than body weight or height. It also reflects neurological integrity and development as well as nutrition, socioeconomic state, and underlying diseases.5

It also reflects neurological integrity and development as well as nutrition socio economic state or underlying diseases.6Maternal/paternal factors influence an entity’s genesis, growth, development, and fall, with genetic and environmental factors potentially disrupting normal synthesis. Teeth appear earlier in girls than boys, creating less trouble because of soft gums and porous teeth.7

To aid in all such concerns Acharya Vaghbhata in Astangahrudaya Uttaratantra has mentioned a few formulations, among which the pratisarana of Pippali churna was mentioned in delayed dentition.8

The mechanism of action involves mechanical pressure exerted during application, which removes debris and biofilm while increasing local blood circulation and enhancing gingival defence mechanisms ,9,10,11. This dual action of mechanical stimulation and pharmacological intervention makes Pratisarana particularly suitable for conditions requiring both local drug delivery and tissue stimulation.

By taking placebo as control group the treatment for delay dentition can be clearly understood as whether mechanical pressure exerted during application is causing the dentition to reappear or the Pharmacological intervention of the medication along with mechanical pressure.

Hence, the drug Pippali churna  pratisarana with madhu has been taken for the present study to evaluate its efficacy in children with delayed dentition and will be compared to placebo (rice floor) pratisarana.

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
10.00 Month(s) 至 24.00 Month(s)(—)
性别
All

入选标准

  • Children born at term a having normal birth weight with Delayed Dentition will be included.

排除标准

  • Children with delayed dentition associated with rickets, hypothyroidism, genetic syndrome and oral malformation (cleft lip and palate) with any severe illness will be excluded.

研究者

发起方
Dr Snehal Bhausaheb Bargal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Snehal Bhausaheb Bargal

Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College,koppal

研究点 (1)

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