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CTRI Number  CTRI/2025/05/086704 [Registered on: 09/05/2025] Trial Registered Prospectively
Last Modified On: 07/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Clinical and Radiographic Evaluation of mixture of Endoflas FS powder with Tulsi extract and Endoflas FS as an root canal material in milk teeth: An In Vivo study. 
Scientific Title of Study   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. 
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 Kiran Patro 
Designation  PostGraduate 
Affiliation  Bharati Vidyapeeth (Deemed to be University), Dental College and Hospital, SANGLI 
Address  Bharati Vidyapeeth Dental College and Hospital, Wanlesswadi, Sangli-Miraj road, Sangli

Sangli
MAHARASHTRA
416416
India 
Phone  9404173636  
Fax    
Email  kiran.patro96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sandhyarani Huddar 
Designation  Associate Professor 
Affiliation  Bharati Vidyapeeth (Deemed to be University), Dental College and Hospital, SANGLI 
Address  Bharati Vidyapeeth Dental College and Hospital, Wanlesswadi, Sangli-Miraj road, Sangli

Sangli
MAHARASHTRA
416416
India 
Phone  8624896052  
Fax    
Email  sandhyadayahuddar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kiran Patro 
Designation  PostGraduate 
Affiliation  Bharati Vidyapeeth (Deemed to be University), Dental College and Hospital, SANGLI 
Address  Bharati Vidyapeeth Dental College and Hospital, Wanlesswadi, Sangli-Miraj road, Sangli

Sangli
MAHARASHTRA
416416
India 
Phone  9404173636  
Fax    
Email  kiran.patro96@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth (Deemed to be University) Dental College & Hospital, Sangli. Maharashtra. Pincode: 416416. Country: India 
 
Primary Sponsor  
Name  Dr Kiran Patro 
Address  Bharati Vidyapeeth (Deemed to Be University) Dental College and Hospital, Sangli, Maharashtra. Pincode: 416416. Country: India 
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 
DrKiran Patro  Department of Pedodontics and Preventive Dentistry  Department No.106, Ground floor, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Sangli, Maharashtra. Pincode: 416416. Country: India
Sangli
MAHARASHTRA 
9404173636

kiran.patro96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Medical College & Hospital, Sangli.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy children who require dental treatment of carious teeth 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endoflas FS  This obturating material has been proven to be the new gold standard for obturation in deciduous teeth which contains eugenol. This procedure is administered into the canals of the primary teeth. The total duration is 30-45 minutes 
Intervention  Endoflas FS powder with Ocimum Sanctum Extract  This is a type of herbal obturating material for pulpectomy in deciduous teeth. it will be administered into the canals of the primary teeth. The procedure takes 30-40 mins to complete 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  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.
3) Children whose parents give consent for the study

Radiographic criteria
1) Atleast 2/3rd of the root present
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinically and radiographically, mixture of ENDOFLAS-FS’s powder with OCIMUM SANCTUM extract can beused as an obturating material in primary molars.  Evaluation at 1 month, 3 months, and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
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. 
 
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   N/A 
Date of First Enrollment (India)   31/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
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.

 
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