| 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. |
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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 |
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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, |
|
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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
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Alternation |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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