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Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation

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ClinicalTrials.gov Identifier: NCT03964766
Recruitment Status : Not yet recruiting
First Posted : May 28, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Azhar Abdulrahman Ali Saleh Al-wesabi, Cairo University

Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date July 19, 2019
Estimated Study Start Date  ICMJE December 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2019)
  • Postoperative pain: modified wong-baker pain rating scale [ Time Frame: 12 hours ]
    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
  • postoperative pain: modified wong-baker pain rating scale [ Time Frame: 24 hours ]
    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
  • postoperative pain: modified wong-baker pain rating scale [ Time Frame: 48 hours ]
    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
  • Postoperative pain: modified wong-baker pain rating scale [ Time Frame: 72 hours ]
    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • postoperative pain: modified wong-baker pain rating scale [ Time Frame: 6 hours ]
    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
  • Postoperative pain: modified wong-baker pain rating scale [ Time Frame: 12 hours ]
    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
  • postoperative pain: modified wong-baker pain rating scale [ Time Frame: 24 hours ]
    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
  • postoperative pain: modified wong-baker pain rating scale [ Time Frame: 48 hours ]
    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
  • Postoperative pain: modified wong-baker pain rating scale [ Time Frame: 72 hours ]
    pain will be assessed using modified wong-baker pain rating scale (0-3),(zero)-no pain; ( one)-slight pain; (two)-moderate pain; and (three)-severe pain.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019)
  • Tenderness to percussion [ Time Frame: Up to 1 year ]
    Percussion test ,Binary (+/-)
  • Fistula [ Time Frame: Up to 1 year ]
    Visual examination by operator,Binary (+/-)
  • Instrumentation time [ Time Frame: 15 Minutes ]
    The time spent using both techniques will be measured and compared between the groups. The time will be recorded in minutes using a stopwatch since the beginning of instrumentation until the beginning of restorative procedure.
  • Furcation or periapical radiolucency [ Time Frame: 6 month ]
    Digital Radiograph ,Binary (+/-)
  • Furcation or periapical radiolucency [ Time Frame: 12 month ]
    Digital Radiograph ,Binary (+/-)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation
Official Title  ICMJE Postoperative Pain Following Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation: A Randomized Clinical Trial
Brief Summary

One of the major concerns in pediatric dentistry is premature loss of necrotic primary teeth which may cause a deleterious effect on the growth of the facial skeletal complex. In order to sustain the primary tooth as a natural space maintainer, pulpectomy is considered the treatment of choice.

The essential part of endodontic treatment is to shape and clean the root canal effectively from infected tissue with microbial reduction, whilst maintaining the original configuration without creating any procedural errors . Even though, manual instrumentation as used for that purpose in deciduous teeth, presents some limitation concerning root canal cleaning, anatomical fidelity and chair-side time.

To achieve successful pulpectomy technique for the primary dentition in a fast and simple procedure, with short chair time as well as effective debridement of the root canals, rotary instrumentation is one of the methods recommended over the manual.

Detailed Description
  1. Trial design:

    Randomized clinical trial, parallel groups design with 1:1 allocation ratio.

  2. Method:

    Interventions

    A. Diagnostic procedure:

    • Clinical examination will be done on the dental clinic using mirror and probe to assess the eligibility.
    • Diagnosis of the cases will be performed according to guidelines of AAPD 2017 for treatment of vital pulp therapy in primary teeth.
    • An individual XCP (Extension Cone Paralleling) index will be prepared for each patient by registering the bite to allow consistent comparisons of the radiographs.
    • Preoperative periapical radiograph and photographs will be taken a baseline record.

    B. Intra operative procedure:

    • Local anesthesia administration using articaine 4% with epinephrine 1:100000.
    • Rubber dam application and access cavity preparation will be established using a sterile bur.
    • Coronal pulp tissue will be removed using sharp large spoon excavator.
    • Working length will be determined using no 15 hand K-file that will be kept 2mm short of radiographic apex.
    • Then, the root canal preparation will be done

      • In control group, hand instrumentation will be carried out using hand K-file up to no. 30 K-file using quarter turn and pull motion.
      • In intervention group, rotary instrumentation will be preceded by initial hand instrumentation using no. 15 K-file to check the patency. Then, the rotary instrumentation will be done using the Kedo-S rotary files for primary teeth with D1 and E1.
    • Using EDTA gel as a lubricating paste during canal preparation with rotary files.
    • Saline irrigation for removal of debris after each file.
    • Dryness will be done using paper points size 35 and 40.
    • Root canals will be obturated using calcium hydroxide iodoform paste (Metapex). The Metapex syringe willbe inserted into the root canal space, near the apex. The paste will be pressed down into the canals and the syringe will be slowly withdrawn.
    • The access cavity will be sealed using GC Fuji IX capsule.
    • The immediate postoperative radiograph will be done to reveal optimal filling with metapex.
    • After that, stainless steel crowns will be cemented by Ketac Cem.

    C. Follow up:

    Clinical and radiographic evaluation will be performed at 1week, 3, 6, 9 and 12 months.

    D. Criteria for discontinuing or modifying intervention:

    In case of unsuccessful outcomes of the intervention technique, the case will be managed .

  3. Recruitment:

    Recruitment of the patients will be from the outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Cairo University. Screening of patients will continue until the target population is achieved.

  4. Implementation Co-supervisor; Fatma Korany will assign which participant tooth will be included to either control or intervention groups according to the generated random sequence.
  5. Masking/blinding:

The radiographic outcomes assessor will be blinded in this study. 8- Data collection, management, and analysis: 9- Data collection methods

Baseline data will be collected by the operator through a paper-based Case Report custom made form (CRF) which will be developed by the research team. It will include the following items:

  1. Patient serial number.
  2. Demographic data.
  3. Patients medical history:

    • Past medical history.
    • Any present disease or illness.
    • Current medication.
    • Any specific pre-treatment medication.
  4. Past dental history.
  5. Records for current dental condition (intra-oral examination and caries index). The custom made CRF will be developed before online registration of the study protocol. CRF will be anonymous where patients will be identified by their serial number. The full detailed personal data of the patient will be written in a separate sheet having the patient's serial number for further contact with patient, this sheet can be only seen by the operator and the supervisors. The Co-supervisor; Dr.Fatma Korany, will have the role to monitor the process of data collection and check if there is any incomplete CRF.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic
  • Infection
Intervention  ICMJE
  • Device: Rotary instrumentation
    using pedo rotary files in cleaning and shaping the root canals of infected primary molars
  • Device: Hand instrumentation
    using conventional hand files in cleaning and shaping the root canals of infected primary molars
Study Arms  ICMJE
  • Experimental: rotary instrumentation
    endodontic treatment will be performed with the use of pedo rotary files that will be activated by engine
    Intervention: Device: Rotary instrumentation
  • Active Comparator: hand istrumentation
    endodontic treatment will be performed with the use of conventional hand files
    Intervention: Device: Hand instrumentation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2019)
42
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2019)
38
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Primary posterior teeth requiring pulpectomy.
  • Cooperative patient in age range from 4 to 6 years
  • Absence of internal or external pathologic root resorption.
  • Presence of adequate coronal tooth structure.
  • Two-thirds of each root remaining.
  • Parent or guardian agree for participant in the study

Exclusion Criteria:

  • Excessive mobility.
  • Children lacking cooperative ability.
  • Children with underlying systemic disease.
  • Children with special health care needs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: azhar al-wesabi 01023725522 azharali5255@gmail.com
Contact: Fatma Abdelgawad, PhD fatma.abdelgawad@dentistry.cu.edu.eg
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03964766
Other Study ID Numbers  ICMJE 200277
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: after thesis defense. the study will be published internationally to be available for everyone
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: study will be available within 2 year.
Access Criteria: Not yet
Responsible Party Azhar Abdulrahman Ali Saleh Al-wesabi, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Fatma Abdelgawad, PhD Lecturer of Pediatric Dentistry
Study Chair: Kamal El Motayam, PhD Professor of Pediatric Dentistry
PRS Account Cairo University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP