Comparative evaluation of MTA putty with conventional MTA as a Pulpotomy Medicament in Primary Molars: A randomized clinical study
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Palak shah
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Success of pulpotomy relies on medicament used & there are recent advancement in MTA material which is available in putty consistency which has ease of handling & cause less wastage of material. So, at the end of this study we will come to know if e-MTA putty is clinically and radiographically successful as compared to MTA Angelus.
Study Overview
Brief Summary
Then, M.Torabinejad introduced MTA in endodontics in 1993 as a root end fillingmaterial. It was given approval by the U.S. Food and Drug Administration in1998. MTA has several desirable properties such asbiocompatibility, hydrophilicity, radiopacity, sealing ability, low solubilityand when it comes in contact with fluids forms an apatite like layer on itssurface10,11. Investigators have showed that it can conduct andinduct hard tissue formation. Studies have showed that when MTA is placed onexposed pulp tissue it causes proliferation, differentiation and migration ofodontoblast like cells, which produce a collagen matrix. Thecollagen matrix is then mineralized and produces osteodentine initially and fewweeks to month’s later tertiary dentinal bridge formation occurs and studiesconclude that MTA is a material of choice and can replace Ca (OH)2 for a betteroutcome of pulpotomy procedures .
MTA Angelus(Angelus, Londrina, Brazil /Clinician‘s Choice, New Milford, CT) was launchedin Brazil in 2001 and received FDA approval in 2011. It is mixed with water at3:1 powder: liquid ratio. It’s initial setting time is 15 minutes andcompressive strength is 34 MPa . The pH of MTA is 10.2 aftermixing which rises to 12.5 after 3 hours but there are drawbacks of MTA whichhave been documented it includes discoloration potential of MTA,difficult handling characteristics, high material cost, technique sensitive andcontain heavy metals like aluminium oxide, bismuth oxide and produce aconsiderably waste.
So, new calciumsilicate-based material with improved properties were introduced. Powder/liquid systems require manual mixing. Therefore, premixed bioceramics wereintroduced. The premixed sealer, paste, and putty have the advantage of uniformconsistency and no wastage. These premixed bioceramics are all hydrophilic andrequire moisture from the surrounding tissues to set . Thisputty is delivered through a syringe and thus does not require hand mixing. Thesyringe also gives the clinician the ability to dispense the exact amount ofmaterial needed for the procedure and thus reduces waste. Unlike regular MTA,it does not cause discoloration of remaining tooth structure. It isdimensionally stable, with zero shrinkage and minimal expansion, and has a veryhigh radiopacity.
Kids-e-Dental’s e-MTAputty is a pre-mixed bio-ceramic, insoluble, radiopaque and bioactive pasteconsisting of very fine hydrophilic particles of several mineral oxides. Itscomposition includes tricalcium silicate, dicalcium silicate, tricalciumaluminate and zirconium oxide. It is handy and easy to use, has non stickyconsistency, washout resistance and non-staining and no heavy metals.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 4.00 Year(s) to 9.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Children aged 4-9 years.
- •2.Primary molars with deep caries lesion without spontaneous or persistent pain and with physiological resorption of less than oneâ€third of the root.
- •3.Vital carious pulp exposures that bleed upon entering the pulp chambers and with hemostasis controlled in <5 min.
Exclusion Criteria
- •1.Children with systemic or mental disorders.
- •Teeth eliciting the signs and symptoms of chronic infection such as swelling, mobility, and sinus tract tenderness to percussion.
- •Presence of any radiographic signs that indicate pulp necrosis, such as internal or external root resorption, inter†radicular and/or periradicular bone destruction.
- •Teeth that cannot to be isolated by the rubber dam.
- •Parents who do not give consent for their child to participate in the study.
Outcomes
Primary Outcomes
Success of pulpotomy relies on medicament used & there are recent advancement in MTA material which is available in putty consistency which has ease of handling & cause less wastage of material. So, at the end of this study we will come to know if e-MTA putty is clinically and radiographically successful as compared to MTA Angelus.
Time Frame: 1 day,6 months,12 months
Secondary Outcomes
- Will come to know the best pulpotomy medicament(1 day,6 months,12 months)
