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.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Kiran Patro
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Clinically and radiographically, mixture of ENDOFLAS-FS’s powder with OCIMUM SANCTUM extract can beused as an obturating material in primary molars.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 3.00 Year(s) to 9.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
- •Children whose parents give consent for the study Radiographic criteria 1) Atleast 2/3rd of the root present.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Clinically and radiographically, mixture of ENDOFLAS-FS’s powder with OCIMUM SANCTUM extract can beused as an obturating material in primary molars.
Time Frame: Evaluation at 1 month, 3 months, and 6 months
Secondary Outcomes
- 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.)
Investigators
Dr Kiran Patro
Bharati Vidyapeeth (Deemed to be University), Dental College and Hospital, SANGLI