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Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars

Primary Purpose

Necrotic Primary Molars

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lesion sterilization and tissue repair
zinc oxide and eugenol pulpectomy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotic Primary Molars

Eligibility Criteria

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

Inclusion Criteria:

  • Children:

    1. Aged between 5 years and 7 years.
    2. With deep caries involving pulp in primary molars.
  • Teeth:

    1. Necrotic teeth with or without periapical or furcal lesions.
    2. Primary molars with minimal root resorption not more than 1/3 of root.

Exclusion Criteria:

  • Children:

    1. Children with systemic disease
    2. Previous history of allergy to antibiotics used in the study.
    3. Children that will not attend follow up.
  • Teeth:

    1. Caries in primary teeth exhibiting pre-shedding mobility.
    2. Non restorable teeth.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    3 MIX

    Zinc oxide and Eugenol Pulpectomy

    Arm Description

    Lesion sterilization and tissue repair; preparation of modified triple antibiotic paste tap: the chemotherapeutic agents used are metronidazole tablets 500 mg (flagyl®, sanofi, egypt), ciprofloxacin tablets 500 mg (ciproxcin®,. Epico, egypt,), and doxycycline capsules 100 mg (doxymycin™ dt, el-nile pharmaceuticals, egypt).

    zinc oxide and eugenol (prevestdent pro™, egypt).

    Outcomes

    Primary Outcome Measures

    Post oper3tive pain
    Measured by verbal question to patient/parents
    Post operative pain
    Measured by verbal question to patient/parents
    Post operative pain
    Measured by verbal question to patient/parents
    Tenderness
    Percussion test using back of a dental mirror
    Tenderness
    Percussion test using back of a dental mirror
    Tenderness
    Percussion test using back of a dental mirror
    Swelling /sinus tract or fistula
    Visual examination
    Swelling /sinus tract or fistula
    Visual examination
    Swelling /sinus tract or fistula
    Visual examination
    Tooth mobility
    Mobility test
    Tooth mobility
    Mobility test
    Tooth mobility
    Mobility test

    Secondary Outcome Measures

    Internal /External root resorption
    Radiographic examination
    Furcation involvement /radiolucency
    Radiographic examination

    Full Information

    First Posted
    June 29, 2022
    Last Updated
    July 5, 2022
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05448937
    Brief Title
    Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars
    Official Title
    Clinical And Radiographic Evaluation Of Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2022 (Anticipated)
    Primary Completion Date
    August 2023 (Anticipated)
    Study Completion Date
    September 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

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the clinical and radiographic success of Lesion Sterilization And Tissue Repair [ LSTR] antibiotic paste versus Zinc Oxide and Eugenol pulpectomy in the treatment of non-vital primary molars.
    Detailed Description
    Primary teeth with infected root canals are a common problem, particularly in patients where the infection has reached the peri radicular tissues . Among the pastes used in the pulp therapy of primary teeth with pulp necrosis, zinc oxide and eugenol paste has been a reference in dentistry since 1930. Endodontic treatment using zinc oxide and eugenol paste has shown satisfactory clinical and radiographic results, requires mechanical chemical preparation before filling root canals. The main difficulties of endodontic treatment of primary molars are related to the anatomical complexity of the root canals and the long time needed to carry out the treatment. The additional difficulty involved in diagnosing root resorption is a limiting condition for determining the actual working length and instrumentation. Other pastes have been studied, such as those containing antibiotics in their composition, thus dispensing with root canal instrumentation (such as lesion sterilization and tissue repair using triple antibiotic paste in treatment of non-vital primary molars. Lesion sterilization and tissue repair using triple antibiotic paste has relevant clinical and radiographic success rates in treatment of non-vital primary molars.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotic Primary Molars

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    3 MIX
    Arm Type
    Experimental
    Arm Description
    Lesion sterilization and tissue repair; preparation of modified triple antibiotic paste tap: the chemotherapeutic agents used are metronidazole tablets 500 mg (flagyl®, sanofi, egypt), ciprofloxacin tablets 500 mg (ciproxcin®,. Epico, egypt,), and doxycycline capsules 100 mg (doxymycin™ dt, el-nile pharmaceuticals, egypt).
    Arm Title
    Zinc oxide and Eugenol Pulpectomy
    Arm Type
    Active Comparator
    Arm Description
    zinc oxide and eugenol (prevestdent pro™, egypt).
    Intervention Type
    Procedure
    Intervention Name(s)
    Lesion sterilization and tissue repair
    Intervention Description
    Pulp therapy for necrotic primary molars
    Intervention Type
    Procedure
    Intervention Name(s)
    zinc oxide and eugenol pulpectomy
    Intervention Description
    Pulp therapy for necrotic primary molars
    Primary Outcome Measure Information:
    Title
    Post oper3tive pain
    Description
    Measured by verbal question to patient/parents
    Time Frame
    1 month
    Title
    Post operative pain
    Description
    Measured by verbal question to patient/parents
    Time Frame
    3 months
    Title
    Post operative pain
    Description
    Measured by verbal question to patient/parents
    Time Frame
    6 months
    Title
    Tenderness
    Description
    Percussion test using back of a dental mirror
    Time Frame
    1 month
    Title
    Tenderness
    Description
    Percussion test using back of a dental mirror
    Time Frame
    3 months
    Title
    Tenderness
    Description
    Percussion test using back of a dental mirror
    Time Frame
    6 months
    Title
    Swelling /sinus tract or fistula
    Description
    Visual examination
    Time Frame
    1 month
    Title
    Swelling /sinus tract or fistula
    Description
    Visual examination
    Time Frame
    3 months
    Title
    Swelling /sinus tract or fistula
    Description
    Visual examination
    Time Frame
    6 months
    Title
    Tooth mobility
    Description
    Mobility test
    Time Frame
    1 month
    Title
    Tooth mobility
    Description
    Mobility test
    Time Frame
    3 months
    Title
    Tooth mobility
    Description
    Mobility test
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Internal /External root resorption
    Description
    Radiographic examination
    Time Frame
    6 months
    Title
    Furcation involvement /radiolucency
    Description
    Radiographic examination
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children: Aged between 5 years and 7 years. With deep caries involving pulp in primary molars. Teeth: Necrotic teeth with or without periapical or furcal lesions. Primary molars with minimal root resorption not more than 1/3 of root. Exclusion Criteria: Children: Children with systemic disease Previous history of allergy to antibiotics used in the study. Children that will not attend follow up. Teeth: Caries in primary teeth exhibiting pre-shedding mobility. Non restorable teeth.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Esraa Mohamed Abdeltawab, B.D.S
    Phone
    01065074062
    Email
    esraa_abdeltawab94@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shereen Hassan El shamy, Lecturer

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29073902
    Citation
    Chen X, Liu X, Zhong J. Clinical and radiographic evaluation of pulpectomy in primary teeth: a 18-months clinical randomized controlled trial. Head Face Med. 2017 Oct 27;13(1):12. doi: 10.1186/s13005-017-0145-1.
    Results Reference
    background
    PubMed Identifier
    30289365
    Citation
    Luengo-Fereira J, Ayala-Jimenez S, Carlos-Medrano LE, Toscano-Garcia I, Anaya-Alvarez M. Clinical and Radiographic Evaluation of Formocresol and Chloramphenicol, Tetracycline and Zinc Oxide-Eugenol Antibiotic Paste in Primary Teeth Pulpotomies: 24 month follow up. J Clin Pediatr Dent. 2019;43(1):16-21. doi: 10.17796/1053-4625-43.1.4. Epub 2018 Oct 5.
    Results Reference
    background
    PubMed Identifier
    34937613
    Citation
    Moura J, Lima M, Nogueira N, Castro M, Lima C, Moura M, Moura L. LSTR Antibiotic Paste Versus Zinc Oxide and Eugenol Pulpectomy for the Treatment of Primary Molars with Pulp Necrosis: A Randomized Controlled Trial. Pediatr Dent. 2021 Nov 15;43(6):435-442.
    Results Reference
    background
    PubMed Identifier
    27790570
    Citation
    Navit S, Jaiswal N, Khan SA, Malhotra S, Sharma A, Mukesh, Jabeen S, Agarwal G. Antimicrobial Efficacy of Contemporary Obturating Materials used in Primary Teeth- An In-vitro Study. J Clin Diagn Res. 2016 Sep;10(9):ZC09-ZC12. doi: 10.7860/JCDR/2016/21883.8426. Epub 2016 Sep 1.
    Results Reference
    background
    PubMed Identifier
    26059708
    Citation
    Pramila R, Muthu MS, Deepa G, Farzan JM, Rodrigues SJ. Pulpectomies in primary mandibular molars: a comparison of outcomes using three root filling materials. Int Endod J. 2016 May;49(5):413-21. doi: 10.1111/iej.12478. Epub 2015 Jul 4.
    Results Reference
    background
    PubMed Identifier
    33087217
    Citation
    Coll JA, Dhar V, Vargas K, Chen CY, Crystal YO, AlShamali S, Marghalani AA. Use of Non-Vital Pulp Therapies in Primary Teeth. Pediatr Dent. 2020 Sep 15;42(5):337-349.
    Results Reference
    background
    PubMed Identifier
    31206571
    Citation
    Zacharczuk GA, Toscano MA, Lopez GE, Ortolani AM. Evaluation of 3Mix-MP and pulpectomies in non-vital primary molars. Acta Odontol Latinoam. 2019 Apr 1;32(1):22-28.
    Results Reference
    background
    PubMed Identifier
    29852056
    Citation
    Smail-Faugeron V, Glenny AM, Courson F, Durieux P, Muller-Bolla M, Fron Chabouis H. Pulp treatment for extensive decay in primary teeth. Cochrane Database Syst Rev. 2018 May 31;5(5):CD003220. doi: 10.1002/14651858.CD003220.pub3.
    Results Reference
    background

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    Lesion Sterilization And Tissue Repair Versus Zinc Oxide And Eugenol For Treatment of Necrotic Primary Molars

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