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Clinical and Radiographic Evaluation of the Synergistic Effect of Nano Silver Particles and Calcium Hydroxide Versus Triple Antibiotic Paste as Antibacterial Agents for Lesion Sterilization and Tissue Repair (LSTR) in Necrotic Primary Molars

Primary Purpose

Root Canal Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nano silver particles and calcium hydroxide
TAP
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Canal Infection focused on measuring primary teeth, LSTR, necrotic

Eligibility Criteria

4 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Children aged between 4 years and 7 years. Restorable necrotic mandibular second primary molars Mandibular lower second primary molar with signs of radiolucency in periapical or furcation area. Mandibular lower second primary molar with widening of PDL space or loss of lamina dura continuity. Mandibular lower second primary molar with evidence of internal/external pathologic root resorption. Signs of radiolucency in periapical or furcation area. Widening of PDL space or loss of lamina dura continuity. Evidence of internal/external pathologic root resorption. External root resorption from 1% to 50%. Exclusion Criteria: Children that are not apparently healthy. Lack of informed consent by the child patient's parent. Patients allergic to any antibiotic used in the preparation of the TAP. Unable to attend follow-up visits. Refusal of participation. External root resorption above 50%.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    LSTR in necrotic primary second molar using TAP

    LSTR in necrotic primary second molar using nano silver particles and calcium hydroxide

    Arm Description

    Triple antibiotic paste (TAP) is considered the gold standard in LSTR. It is a combination of ciprofloxacin, metronidazole and minocycline. Many anaerobic bacteria are resistant to ciprofloxacin. Hence, it is often used with metronidazole in treating mixed infections to compensate for its limited scope. Therefore, TAP can affect gram-negative, gram-positive, and anaerobic bacteria, and this combination can be effective against odontogenic microorganisms.

    Nano silver particles have a strong anti-bacterial properties due to its ability to target the bacteria on different cellular levels. Calcium hydroxide has been used for so long as an intra canal medication in odontogenic infections due to its strong alkalinity that gives it its anti bacterial properties. This combination might be a future alternative to antibiotics, in an attempt to decrease the bacterial antibiotic resistance and antibiotics use.

    Outcomes

    Primary Outcome Measures

    Pathological mobility
    presence/ absence. Mobility test by applying pressure using the handle of dental mirrors
    Post-operative pain
    presence/ absence. Verbal question to patient/ parent.
    Soft tissue pathology
    presence/ absence. Visual clinical examination
    Pain to percussion
    presence/ absence. Percussion test by the handle of the dental mirror

    Secondary Outcome Measures

    Absence of furcation or periapical radiolucency
    Intra-oral digital peri-apical x-ray
    Absence of external or internal root resorption
    Intra-oral digital peri-apical x-ray

    Full Information

    First Posted
    December 13, 2022
    Last Updated
    December 26, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05681221
    Brief Title
    Clinical and Radiographic Evaluation of the Synergistic Effect of Nano Silver Particles and Calcium Hydroxide Versus Triple Antibiotic Paste as Antibacterial Agents for Lesion Sterilization and Tissue Repair (LSTR) in Necrotic Primary Molars
    Official Title
    Clinical and Radiographic Evaluation of the Synergistic Effect of Nano Silver Particles and Calcium Hydroxide Versus Triple Antibiotic Paste as Antibacterial Agents for Lesion Sterilization and Tissue Repair (LSTR) in Necrotic Primary Molars: Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 20, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Could the clinical and radiographic success of Nano Silver Particles and Calcium Hydroxide be comparable to that of Triple Antibiotic Paste as antibacterial agents for Lesion Sterilization and Tissue Repair (LSTR) in necrotic second primary molars?
    Detailed Description
    The major aim of pediatric dentistry is to maintain the integrity of the primary dentition until physiologic exfoliation. Premature loss of primary teeth may lead to several complications, like disturbance in eruption sequence, ectopic eruption and space loss. Hence, the conservation of primary tooth structure is essential, provided that it can be restored to function and remain free from disease.Pulp therapy in primary teeth at times become contraindicated or compromised due to excessive root resorption, inadequate bone and periodontal support, a child with pre-cooperative age group, etc. In the current era, a new perspective which is less invasive and less time consuming procedure could be a spark of hope for pedodontists. The Lesion Sterilization and Tissue Repair (LSTR) claims its significance in such clinical situation. The concept of LSTR was developed at the Cariology Research Unit of Niigata University School of Dentistry. The LSTR is an endodontic treatment procedure that involves non instrumentation or minimal instrumentation followed by placement of antibiotic mixture to disinfect root canal systems, and periapical lesions. The basic concept of LSTR is "do not remove or touch and leave it.". The principle behind LSTR is repair by natural defense mechanisms of host; Sterilizing the root canals and pulp chamber by medicaments can decrease the bacterial load. If the procedure is successful tissue repair can be expected. However, because it is impossible to eradicate all microorganisms from the root canal system throughout the treatment, endodontic materials must contain specific components that release antibacterial substances. The most likely cause for this is the complex anatomy of the root canal system, which allows bacteria to colonize in inaccessible places to antimicrobial agents. Despite cleaning, and administration of highly effective antimicrobial agents, clinical trials have shown that bacteria remain within the root canal system because bacteria can form biofilms, infiltrate dentinal tubules, and cause monoinfection. Among the intra canal medicaments, calcium hydroxide is most frequently used because of its wide antimicrobial spectrum. Calcium hydroxide Ca(OH)2 is commonly employed as an intra canal medicament. It releases hydroxyl ions which causes high alkalinity. Nevertheless, the ability of calcium hydroxide in elimination of bacteria from the root canal has been questioned. Antibacterial ability of calcium hydroxide in aqueous environment is linked to the discharge of hydroxyl ions. It can cause damage to the cytoplasmic membrane, bacterial DNA as well as can cause protein denaturation. However, calcium hydroxide is not as much effective when used for canal disinfection having established Enterococcus faecalis (E.faecalis) biofilm. Recently, numerous studies have introduced silver nanoparticles as an antimicrobial agent. Silver nanoparticles have antimicrobial activity and are biocompatible, silver ions can cause damage to the bacterial cell wall. These are productive against many microorganisms including E.faecalis. Nanoparticles have /polyanionic polycationic properties with a high surface area and positive charge density, which increases their antibacterial activity. The particle size was also related to antimicrobial activity; the smaller particles give more bactericidal effects compared to larger particles. Calcium hydroxide do not always eradicate E.faecalis biofilm from root canals. Hence, it is essential to introduce advanced endodontic intra-canal medicament approaches that are successful in eradicating biofilm bacteria inside the root canals.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Root Canal Infection
    Keywords
    primary teeth, LSTR, necrotic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    TAP is an efficient antibacterial for the disinfection of the periapical area in the necrotic primary second molars as well as the infected dentinal tubules. It is effective against the persistent odontogenic infections.
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    LSTR in necrotic primary second molar using TAP
    Arm Type
    Active Comparator
    Arm Description
    Triple antibiotic paste (TAP) is considered the gold standard in LSTR. It is a combination of ciprofloxacin, metronidazole and minocycline. Many anaerobic bacteria are resistant to ciprofloxacin. Hence, it is often used with metronidazole in treating mixed infections to compensate for its limited scope. Therefore, TAP can affect gram-negative, gram-positive, and anaerobic bacteria, and this combination can be effective against odontogenic microorganisms.
    Arm Title
    LSTR in necrotic primary second molar using nano silver particles and calcium hydroxide
    Arm Type
    Experimental
    Arm Description
    Nano silver particles have a strong anti-bacterial properties due to its ability to target the bacteria on different cellular levels. Calcium hydroxide has been used for so long as an intra canal medication in odontogenic infections due to its strong alkalinity that gives it its anti bacterial properties. This combination might be a future alternative to antibiotics, in an attempt to decrease the bacterial antibiotic resistance and antibiotics use.
    Intervention Type
    Other
    Intervention Name(s)
    Nano silver particles and calcium hydroxide
    Intervention Description
    Combination of two materials that can possibly eradicate the mixed odontogenic infection in the periapical area and dentinal tubules in necrotic primary second molars.
    Intervention Type
    Other
    Intervention Name(s)
    TAP
    Intervention Description
    Triple antibiotic paste (TAP) is considered the gold standard in LSTR. It is a combination of ciprofloxacin, metronidazole and minocycline. Many anaerobic bacteria are resistant to ciprofloxacin. Hence, it is often used with metronidazole in treating mixed infections to compensate for its limited scope. Therefore, TAP can affect gram-negative, gram-positive, and anaerobic bacteria, and this combination can be effective against odontogenic microorganisms.
    Primary Outcome Measure Information:
    Title
    Pathological mobility
    Description
    presence/ absence. Mobility test by applying pressure using the handle of dental mirrors
    Time Frame
    1 year.
    Title
    Post-operative pain
    Description
    presence/ absence. Verbal question to patient/ parent.
    Time Frame
    1 year.
    Title
    Soft tissue pathology
    Description
    presence/ absence. Visual clinical examination
    Time Frame
    1 year.
    Title
    Pain to percussion
    Description
    presence/ absence. Percussion test by the handle of the dental mirror
    Time Frame
    1 year.
    Secondary Outcome Measure Information:
    Title
    Absence of furcation or periapical radiolucency
    Description
    Intra-oral digital peri-apical x-ray
    Time Frame
    1 year.
    Title
    Absence of external or internal root resorption
    Description
    Intra-oral digital peri-apical x-ray
    Time Frame
    1 year.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children aged between 4 years and 7 years. Restorable necrotic mandibular second primary molars Mandibular lower second primary molar with signs of radiolucency in periapical or furcation area. Mandibular lower second primary molar with widening of PDL space or loss of lamina dura continuity. Mandibular lower second primary molar with evidence of internal/external pathologic root resorption. Signs of radiolucency in periapical or furcation area. Widening of PDL space or loss of lamina dura continuity. Evidence of internal/external pathologic root resorption. External root resorption from 1% to 50%. Exclusion Criteria: Children that are not apparently healthy. Lack of informed consent by the child patient's parent. Patients allergic to any antibiotic used in the preparation of the TAP. Unable to attend follow-up visits. Refusal of participation. External root resorption above 50%.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sohair M. Aly, BSc
    Phone
    +201006202025
    Email
    sohair_magdy@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reem M. Wahby, PhD
    Email
    reemwahby@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rania A. Nasr, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    Citation
    Shetty A, Geethanjali G, Hegde A. Lesion sterilization and tissue repair in primary teeth. SRM Journal of Research in Dental Sciences. 2020;11(2):99. doi:10.4103/srmjrds.srmjrds_87_19
    Results Reference
    background
    PubMed Identifier
    14871180
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34290069
    Citation
    Motiwala MA, Habib S, Ghafoor R, Irfan S. Comparison of antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of chronic apical periodontitis: a randomised controlled trial study protocol. BMJ Open. 2021 Jul 21;11(7):e048947. doi: 10.1136/bmjopen-2021-048947.
    Results Reference
    background
    PubMed Identifier
    23323217
    Citation
    Mohammadi Z, Shalavi S, Yazdizadeh M. Antimicrobial activity of calcium hydroxide in endodontics: a review. Chonnam Med J. 2012 Dec;48(3):133-40. doi: 10.4068/cmj.2012.48.3.133. Epub 2012 Dec 21.
    Results Reference
    background
    PubMed Identifier
    26327612
    Citation
    Afkhami F, Pourhashemi SJ, Sadegh M, Salehi Y, Fard MJ. Antibiofilm efficacy of silver nanoparticles as a vehicle for calcium hydroxide medicament against Enterococcus faecalis. J Dent. 2015 Dec;43(12):1573-9. doi: 10.1016/j.jdent.2015.08.012. Epub 2015 Aug 29.
    Results Reference
    background
    Citation
    Zapór L. Effects of silver nanoparticles of different sizes on cytotoxicity and oxygen metabolism disorders in both reproductive and respiratory system cells. Archives of Environmental Protection. 2016;42(4):32-47. doi:10.1515/aep-2016-0038
    Results Reference
    background
    Citation
    Riaz Z, Raza M, Hanif A, Haider B, Akram S, Safdar S. Antibacterial efficacy of silver nanoparticles impregnated calcium hydroxide: An in vitro study. J Pak Dent Assoc 2022;31(1):1-4
    Results Reference
    background
    PubMed Identifier
    34720513
    Citation
    Deepak BM, Prabhakar AR, Karuna YM, Sugandhan S, Zahoor N, Mahendrapa Shagale A. Evaluation of the Antibacterial Activity of Triclosan-incorporated Root Canal Filling Materials for Primary Teeth against Enterococcus faecalis. Int J Clin Pediatr Dent. 2021 May-Jun;14(3):393-397. doi: 10.5005/jp-journals-10005-1960.
    Results Reference
    background

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    Clinical and Radiographic Evaluation of the Synergistic Effect of Nano Silver Particles and Calcium Hydroxide Versus Triple Antibiotic Paste as Antibacterial Agents for Lesion Sterilization and Tissue Repair (LSTR) in Necrotic Primary Molars

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