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The Effect of Using 70% Ethanol Alcohol as a Root Canal Irrigant on Increasing the Success Rate of Metapex in Pulpectomy Compared to Normal Saline in Primary Molars

Primary Purpose

Pulpitis - Irreversible, Resorption, Root, Abscess Bone

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
70% Ethanol Alcohol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulpitis - Irreversible focused on measuring Metapex, Primary dentition

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients medically within normal.
  2. Cooperative patients and cooperative parents.
  3. Children aged 4-7 years old.
  4. Primary mandibular second molar.
  5. Deep carious molars.
  6. A history of spontaneous pain.
  7. Molars with pulp exposure due to caries.
  8. Absences of Internal resorption.
  9. Absences of external pathological resorption.
  10. where the bleeding could not be stopped following removal of the coronal pulp tissue

Exclusion Criteria:

  1. Parents unable to give informed consent.
  2. Necrotic pulp.
  3. Unrestorable Teeth.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    70% Ethanol

    Normal Saline

    Arm Description

    Using 70% Ethanol Alcohol as a root canal irrigating solution before obturating the lower primary second molar with Metapex

    Irrigating the canals with Normal Saline before obturating the lower primary second molar with Metapex

    Outcomes

    Primary Outcome Measures

    Postoperative pain of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
    Assessment through Visual Analog Scale , A score from (0-10) 0 is means no pain and 10 is the maximum level of pain.

    Secondary Outcome Measures

    Radiographic evaluation of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
    Assessment through Visual interpretation of digital radiograph

    Full Information

    First Posted
    December 12, 2020
    Last Updated
    July 24, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04669392
    Brief Title
    The Effect of Using 70% Ethanol Alcohol as a Root Canal Irrigant on Increasing the Success Rate of Metapex in Pulpectomy Compared to Normal Saline in Primary Molars
    Official Title
    Clinical and Radiographic Evaluation of 70% Ethanol Alcohol Versus Normal Saline as Root Canal Irrigating Solutions in Partial Pulpectomy of Primary Molars With Metapex A Randomized Controlled (Pilot Trial)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    January 1, 2023 (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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of the study is to perform a clinical and radiographic evaluation of 70% Ethanol Alcohol versus Normal Saline as root canal irrigating solutions in partial pulpectomy of primary molars with Metapex.
    Detailed Description
    In permanent dentition, Calcium Hydroxide-Iodoform paste (Metapex) has a high potential in forming a calcific barrier in the pulpal tissue. Yet, in primary dentition Metapex forms a chronic inflammatory reaction to the pulpal tissue leading to its internal and root resorption. Although the high success rate of Metapex in partial pulpectomy, the rapid resorption of Metapex has led to the presence of the hollow tube effect due to voids formation in the canals. However, this will cause early root resorption before the time of exfoliation. Due to its rapid resorption, Metapex is usually recommended to be used in the pulpectomy of teeth near exfoliation in order to avoid the early root resorption of primary dentition in order to avoid the premature loss of the endodontically treated vital primary teeth with Metapex. Saline solution is the basic irrigating solution in root canal treatments, yet it has no antimicrobial activities and only results in cleaning the root canals. Ethanol irrigation is believed to be an alternative promising replacement in tissue fixation from Formocresol due to the concerns from its carcinogenicity and toxicity. Also, Ethanol has an excellent bactericidal, virucidal, and fungicidal, and most importantly it is one of the volatile liquids. In this study, the effect of Ethanol Alcohol on increasing the success rate of Metapex in vital pulp therapy will be studied.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulpitis - Irreversible, Resorption, Root, Abscess Bone, Mobility, Tooth, Pain
    Keywords
    Metapex, Primary dentition

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    70% Ethanol
    Arm Type
    Experimental
    Arm Description
    Using 70% Ethanol Alcohol as a root canal irrigating solution before obturating the lower primary second molar with Metapex
    Arm Title
    Normal Saline
    Arm Type
    No Intervention
    Arm Description
    Irrigating the canals with Normal Saline before obturating the lower primary second molar with Metapex
    Intervention Type
    Drug
    Intervention Name(s)
    70% Ethanol Alcohol
    Intervention Description
    Ethanol, also called ethyl alcohol, grain alcohol, or alcohol, a member of a class of organic compounds that are given the general name alcohols. Ethanol is a commonly used fixative. Fixation of the inner layers of the tissue depends on the ability of the fixative to diffuse into the tissue. Moreover, Ethanol has antibacterial antifungal, and antiviral properties. 70% Ethanol is the safest concentration because the water that has been mixed into the ethanol slows the drying time, creating a longer contact time. Ethanol needs to have a contact time of at least 10 seconds to kill Staphylococcus aureus and Streptococcus pyogenes. At a 10 second drying time.
    Primary Outcome Measure Information:
    Title
    Postoperative pain of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
    Description
    Assessment through Visual Analog Scale , A score from (0-10) 0 is means no pain and 10 is the maximum level of pain.
    Time Frame
    Patients will be assessed at 12 months follow ups
    Secondary Outcome Measure Information:
    Title
    Radiographic evaluation of partial pulpectomy of Metapex using both 70% Ethanol Alcohol and Normal Saline as root canal irrigating solutions.
    Description
    Assessment through Visual interpretation of digital radiograph
    Time Frame
    Patients will be assessed at 12 months follow ups

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients medically within normal. Cooperative patients and cooperative parents. Children aged 4-7 years old. Primary mandibular second molar. Deep carious molars. A history of spontaneous pain. Molars with pulp exposure due to caries. Absences of Internal resorption. Absences of external pathological resorption. where the bleeding could not be stopped following removal of the coronal pulp tissue Exclusion Criteria: Parents unable to give informed consent. Necrotic pulp. Unrestorable Teeth.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Thamat Al-Gannah SM Rashed, Bachelor's degree of dentistry
    Phone
    00201111760022
    Email
    ThamarAlGannah.Mohamed@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    Brand, C. & At, D. M. E. Guidelines for Disinfection and Sterilization in Healthcare Facilities , 2008 ( Centers for Disease Control ). 2008, (2008).
    Results Reference
    background
    PubMed Identifier
    11132515
    Citation
    Nurko C, Ranly DM, Garcia-Godoy F, Lakshmyya KN. Resorption of a calcium hydroxide/iodoform paste (Vitapex) in root canal therapy for primary teeth: a case report. Pediatr Dent. 2000 Nov-Dec;22(6):517-20.
    Results Reference
    result
    PubMed Identifier
    26838149
    Citation
    Al-Ostwani AO, Al-Monaqel BM, Al-Tinawi MK. A clinical and radiographic study of four different root canal fillings in primary molars. J Indian Soc Pedod Prev Dent. 2016 Jan-Mar;34(1):55-9. doi: 10.4103/0970-4388.175515.
    Results Reference
    result
    PubMed Identifier
    27274150
    Citation
    Thiruvenkadam G, Asokan S, John B, Priya PG. Effect of 95% Ethanol as a Final Irrigant before Root Canal Obturation in Primary Teeth: An in vitro Study. Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):21-4. doi: 10.5005/jp-journals-10005-1327. Epub 2016 Apr 22.
    Results Reference
    result
    PubMed Identifier
    31277893
    Citation
    Panzacchi S, Gnudi F, Mandrioli D, Montella R, Strollo V, Merrick BA, Belpoggi F, Tibaldi E. Effects of short and long-term alcohol-based fixation on Sprague-Dawley rat tissue morphology, protein and nucleic acid preservation. Acta Histochem. 2019 Aug;121(6):750-760. doi: 10.1016/j.acthis.2019.05.011. Epub 2019 Jul 3.
    Results Reference
    result

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    The Effect of Using 70% Ethanol Alcohol as a Root Canal Irrigant on Increasing the Success Rate of Metapex in Pulpectomy Compared to Normal Saline in Primary Molars

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