| CTRI Number |
CTRI/2026/01/101519 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of pippali churna gum application in children with delayed dentition eruption of teeth |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trail to Evaluate the Efficacy Of Pippali Churna Pratisarana in Children with Delayed Dentition |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Snehal Bhausaheb Bargal |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College,koppal |
| Address |
OPD NO 13,dept of Kaumarabhritya Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital Koppal Karnataka
Koppal KARNATAKA 583231 India |
| Phone |
8788816984 |
| Fax |
|
| Email |
snehalbargal3@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Snehal Bhausaheb Bargal |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College,koppal |
| Address |
OPD NO 13,Dept of Kaumarabhritya, Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College And Hospital Koppal Karnataka OPD NO 13,Dept of Kaumarabhritya, Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College And Hospital koppal Karnataka Koppal KARNATAKA 583231 India |
| Phone |
8788816984 |
| Fax |
|
| Email |
snehalbargal3@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Snehal Bhausaheb Bargal |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College,koppal |
| Address |
OPD NO 13,Dept of Kaumarabhritya, Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College And Hospital Koppal Karnataka
Koppal KARNATAKA 583231 India |
| Phone |
8788816984 |
| Fax |
|
| Email |
snehalbargal3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital Koppal Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Bhausaheb Bargal |
| Address |
OPD NO 13, Dept of Kaumarabhritya, Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College And Hospital Koppal Karnataka |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snehal Bhausaheb Bargal |
Shree Gadaguru Gavisiddheshwara Ayurvedic Medical College And Hospital Koppal |
OPD NO 13, dept of Kaumarabhritya Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital Koppal Karnataka Koppal KARNATAKA |
08788816984
snehalbargal3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital koppal karanataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K006||Disturbances in tooth eruption. Ayurveda Condition: DANTAGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pippali churna , Reference: Ashtanga Hrudaya Uttarsthana pratishedha adhyay35th verse, Route: Oral, Dosage Form: Churna/ Powder, Dose: 15(mg), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -madhu), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
10.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
Children born at term a having normal birth weight with Delayed Dentition will be included. |
|
| ExclusionCriteria |
| Details |
Children with delayed dentition associated with rickets, hypothyroidism, genetic syndrome and oral malformation (cleft lip and palate) with any severe illness will be excluded. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| time to first tooth eruption |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| eruption of teeth |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |