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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K006||Disturbances in tooth eruption. Ayurveda Condition: DANTAGATAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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: -
 
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. 
 
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.
 
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