3Mixtatin Versus Modified 3Mix-MP in Lesion Sterilization and Tissue Repair for Treatment of Necrotic Primary Molars

NCT05677945 | Unknown

• 1 other identifier: LSTR in necrotic primary teeth
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Necrotic Primary Molars

Keywords

3MIX-MP; 3Mixtatin; LSTR

Outcome Measures

Primary Outcomes (16)

• 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

• 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

Secondary Outcomes (4)

• 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

Study Arms (2)

(Group I Experimental Group):Simvastatin mixed with modified triple antibiotic (3Mixtatin)

EXPERIMENTAL

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.

Drug: 3Mixtatin paste: Simvastatin mixed with modified triple antibiotic

Group II Control group Modified triple antibiotic mix in propylene glycol (3Mix)

ACTIVE COMPARATOR

* 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.

Drug: 3Mix: Modified triple antibiotic mix in propylene glycol

Interventions

3Mixtatin paste: Simvastatin mixed with modified triple antibiotic DRUG

* 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.

(Group I Experimental Group):Simvastatin mixed with modified triple antibiotic (3Mixtatin)

3Mix: Modified triple antibiotic mix in propylene glycol DRUG

* 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.

Group II Control group Modified triple antibiotic mix in propylene glycol (3Mix)

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aged 4-7 years.
• Positive parental informed consent.
• Restorable necrotic mandibular second primary molars with peri-radicular/furcal involvement and/or pathologic root resorption (external or internal).
• Presence of chronic apical abscess or sinus tract or furcation radiolucency. (Thakur et al., 2021)

You may not qualify if:

• Medically compromised children.
• Children with known allergy to any of the components being utilized.
• Molars near exfoliation.
• Molars with severely resorbed roots more than two thirds indicated for extraction
• Molars with insufficient coronal structure disabling proper coronal seal.
• Presence of periapical or interradicular radiolucent area which could compromise the permanent tooth bud. (Shetty et al., 2020)

Sponsors & Collaborators

• Cairo University: lead

Related Publications (7)

• 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.

  PMID: 35645497 BACKGROUND

• 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.

  PMID: 9206436 BACKGROUND

• 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.

  PMID: 3052845 BACKGROUND

• 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.

  PMID: 26950808 BACKGROUND

• 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.

  PMID: 30787561 BACKGROUND

• 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.

  PMID: 14871180 BACKGROUND

• 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.

  PMID: 35003558 BACKGROUND

MeSH Terms

Interventions

Propylene Glycol

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• Rania Nasr, Professor

  Professor of pediatric dentistry

  STUDY DIRECTOR

Central Study Contacts

Dalia Magdy Al Shamy, BSC

CONTACT

01023363613; dalia.elshamy@dentistry.cu.edu.eg

Maii Mohamed, lecturer

CONTACT

01012632608

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This research will be a double-blinded study, where the patient (participant) and the outcome assessor will be blinded to the treatment group (to avoid detection, reporting and assessment bias). When a patient agrees to participate in the trial, an envelope will be drawn by one of the residents present at the clinic and name, telephone number and patient's I.D. will be written on it. Those selected envelops will be opened at treatment visit after performing access cavity to choose which material should be used. Randomization and allocation concealment will be performed by the co-supervisor to avoid selection bias. The participant will not be aware of which treatment modality he will be receiving. Principal investigator will not be blinded due to differences in preparation of the mix.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Masters Student

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 10, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 10, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share