LSTR
A Randomized Controlled Trial Comparing the Clinical and Radiographic Success of 3Mixtatin Versus Modified 3Mix in Lesion Sterilization and Tissue Repair (LSTR) for The Treatment of Necrotic Primary Molars
Sponsor study identifier
interventional
24
0 countries
N/A
Study Start
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This randomized clinical study aims to assess the clinical and radiographic success rate of the 3Mixtatin versus the 3Mix in LSTR in necrotic primary molars.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 15, 2022
Actual (reported)January 10, 2023
Actual (reported)March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Absence of pathological mobility measured by (Miller's grades)
Miller's Classification * Grade I: first distinguishable sign of movement * Grade II: movement of tooth which allows crown to deviate 1mm of its normal position * Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket. A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
baseline
Absence of pathological mobility measured by (Miller's grades)
Miller's Classification * Grade I: first distinguishable sign of movement * Grade II: movement of tooth which allows crown to deviate 1mm of its normal position * Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket. A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
at 3 months post operative
Absence of pathological mobility measured by (Miller's grades)
Miller's Classification * Grade I: first distinguishable sign of movement * Grade II: movement of tooth which allows crown to deviate 1mm of its normal position * Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket. A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
at 6 months post operative
Status of radiolucency if present at the periapical or at furcation area
baseline
Status of radiolucency if present at the periapical or at furcation area
at 6 months post operative
Status of radiolucency if present at the periapical or at furcation area
at 12 months post operative
Absence of external or internal root resorption
baseline , 6 ,12 months
Patients will then be allocated into either one of the groups alternatively after access cavity preparation depending on the mix to be used as follows: for this group: * 2mg of pure Simvastatin powder will be added to the 1:1:1 3Mix powder and will be stored together in an air tight porcelain container to avoid the exposure to moisture and light. * Upon clinical application the 3Mixtatin powder will be mixed with normal saline to form a paste and is then applied in the same manner as the Modified 3Mix-MP paste.
* Removal of enteric coating/capsule of the three antibiotic tablets using a surgical blade. * 500 mg Metronidazole tab * 500 mg Ciprofloxacin tab * 200 mg Cefixime caps * Pulverization of each of the drug, will be done using a pestle \& mortar, stored in an air tight porcelain container to avoid the exposure to moisture \& light. * Pulverized powders will be stored at a temperature of 16°C.Powder should be allowed to be cooled to the room temperature before initiating the preparation of 3Mix-MP paste. * Powders will be mixed in the proportion of: 1:1:1 by volume (Hoshino et al., 1988). * Vehicle that will be used is Systane eye drops (Kharadly et al., 2022) it contains the two main components propylene Glycol (Macrogol) \& polyethylene glycol. * The prepared antibiotic powder is mixed with the prepared vehicle in the ratio of 7:1 by volume. The two steps above are done after access cavity preparation to obtain a fresh mix.
* Drying the mucosa with gauze,topical anesthesia will be applied. * Administration of local anesthesia with vasoconstrictor. * Rubber dam isolation. * Caries removal \& access cavity using a round bur mounted on a high-speed contra with coolant. * Removal of necrotic pulp tissue in coronal portion of the tooth using sharp excavator. * Radicular section will be kept untouched,no instrumentation. * Using disposable syringe Irrigation of the pulp chamber with 2.5% NaOCl. * In case of hemorrhage moist cotton immersed in 1% NaOCL will be placed to achieve hemostasis. * Drying the access cavity with sterile cotton pellets. * Freshly mixed 3Mix-MP or 3Mixtatin paste (according to group of intervention) will be transferred to the floor of the pulp chamber using an amalgam carrier \& condensed over orifices using a moist cotton pellet. * Cavity sealing with RMGI capsules. * Same visit placement with preformed Stainless-steel crown(3M® ESPE)cemented with glass ionomer cement.
Chak RK, Singh RK, Mutyala J, Killi NK. Clinical Radiographic Evaluation of 3Mixtatin and MTA in Primary Teeth Pulpotomies: A Randomized Controlled. Int J Clin Pediatr Dent. 2022;15(Suppl 1):S80-S86. doi: 10.5005/jp-journals-10005-2216.
Hoshino E, Kurihara-Ando N, Sato I, Uematsu H, Sato M, Kota K, Iwaku M. In-vitro antibacterial susceptibility of bacteria taken from infected root dentine to a mixture of ciprofloxacin, metronidazole and minocycline. Int Endod J. 1996 Mar;29(2):125-30. doi: 10.1111/j.1365-2591.1996.tb01173.x.
Rania Nasr, Professor
Professor of pediatric dentistry
First Submitted
December 15, 2022
First Posted
January 10, 2023
Absence of pathological mobility measured by (Miller's grades)
Miller's Classification * Grade I: first distinguishable sign of movement * Grade II: movement of tooth which allows crown to deviate 1mm of its normal position * Grade III shows noticeable and increased movement of tooth more than 1mm in any direction or the tooth can be depressed into the socket. A reduction in grade of mobility from preoperative baseline will be considered as success while increased mobility will be recorded as failure
at 12 months post operative
Absence of post-operative pain (binary)
Measured by asking the patient to identify presence or absence of pain
baseline
Absence of post-operative pain (binary)
Measured by asking the patient to identify presence or absence of pain
at 3 months post operative
Absence of post-operative pain (binary)
Measured by asking the patient to identify presence or absence of pain
at 6 months post operative
Absence of post-operative pain (binary)
Measured by asking the patient to identify presence or absence of pain
at 12 months post operative
Absence of soft tissue pathologies (binary)
Binary outcome measured visually by intraoral/extraoral examination
baseline
Absence of soft tissue pathologies (binary)
Binary outcome measured visually by intraoral/extraoral examination
at 3 months post operative
Absence of soft tissue pathologies (binary)
Binary outcome measured visually by intraoral/extraoral examination
at 6 months post operative
Absence of soft tissue pathologies (binary)
Binary outcome measured visually by intraoral/extraoral examination
at 12 months post operative
Absence of pain on percussion (binary)
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
baseline
Absence of pain on percussion (binary)
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
at 3 months post operative
Absence of pain on percussion (binary)
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
at 6 months post operative
Absence of pain on percussion (binary)
Binary outcome measured by gentle tapping using the back of the mirror on the tooth
at 12 months post operative
* Drying the mucosa with gauze,topical anesthesia will be applied. * Administration of local anesthesia with vasoconstrictor. * Rubber dam isolation. * Caries removal \& access cavity using a round bur mounted on a high-speed contra with coolant. * Removal of necrotic pulp tissue in coronal portion of the tooth using sharp excavator. * Radicular section will be kept untouched,no instrumentation. * Using disposable syringe Irrigation of the pulp chamber with 2.5% NaOCl. * In case of hemorrhage moist cotton immersed in 1% NaOCL will be placed to achieve hemostasis. * Drying the access cavity with sterile cotton pellets. * Freshly mixed 3Mix-MP or 3Mixtatin paste (according to group of intervention) will be transferred to the floor of the pulp chamber using an amalgam carrier \& condensed over orifices using a moist cotton pellet. * Cavity sealing with RMGI capsules. * Same visit placement with preformed Stainless-steel crown(3M® ESPE)cemented with glass ionomer cement.
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Hoshino E, Kota K, Sato M, Iwaku M. Bactericidal efficacy of metronidazole against bacteria of human carious dentin in vitro. Caries Res. 1988;22(5):280-2. doi: 10.1159/000261121.
Aminabadi NA, Huang B, Samiei M, Agheli S, Jamali Z, Shirazi S. A Randomized Trial Using 3Mixtatin Compared to MTA in Primary Molars with Inflammatory Root Resorption: A Novel Endodontic Biomaterial. J Clin Pediatr Dent. 2016;40(2):95-102. doi: 10.17796/1053-4628-40.2.95.
Sain S, J R, S A, George S, S Issac J, A John S. Lesion Sterilization and Tissue Repair-Current Concepts and Practices. Int J Clin Pediatr Dent. 2018 Sep-Oct;11(5):446-450. doi: 10.5005/jp-journals-10005-1555. Epub 2018 Oct 1.
Takushige T, Cruz EV, Asgor Moral A, Hoshino E. Endodontic treatment of primary teeth using a combination of antibacterial drugs. Int Endod J. 2004 Feb;37(2):132-8. doi: 10.1111/j.0143-2885.2004.00771.x.
Thakur S, Deep A, Singhal P, Chauhan D. A randomized control trial comparing the efficacy of 3Mixtatin and Modified 3Mix-MP paste using lesion sterilization and tissue repair technique to conventional root canal treatment in primary molars of children aged 4-8 years: An in vivo study. Dent Res J (Isfahan). 2021 Nov 22;18:93. doi: 10.4103/1735-3327.330874. eCollection 2021.
Study Start
March 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 10, 2023
Record last verified: 2022-12
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