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Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Chronic Infection Device: Rotary instrumentation Device: Hand instrumentation Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Pain Following Pulpectomy of Primary Molars With Rotary Instrumentation Versus Manual Instrumentation: A Randomized Clinical Trial
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: rotary instrumentation
endodontic treatment will be performed with the use of pedo rotary files that will be activated by engine
Device: Rotary instrumentation
using pedo rotary files in cleaning and shaping the root canals of infected primary molars

Active Comparator: hand istrumentation
endodontic treatment will be performed with the use of conventional hand files
Device: Hand instrumentation
using conventional hand files in cleaning and shaping the root canals of infected primary molars




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Tenderness to percussion [ Time Frame: Up to 1 year ]
    Percussion test ,Binary (+/-)

  2. Fistula [ Time Frame: Up to 1 year ]
    Visual examination by operator,Binary (+/-)

  3. 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.

  4. Furcation or periapical radiolucency [ Time Frame: 6 month ]
    Digital Radiograph ,Binary (+/-)

  5. Furcation or periapical radiolucency [ Time Frame: 12 month ]
    Digital Radiograph ,Binary (+/-)



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964766


Contacts
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Contact: azhar al-wesabi 01023725522 azharali5255@gmail.com
Contact: Fatma Abdelgawad, PhD fatma.abdelgawad@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Fatma Abdelgawad, PhD Lecturer of Pediatric Dentistry
Study Chair: Kamal El Motayam, PhD Professor of Pediatric Dentistry
Additional Information:
Publications:
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Responsible Party: Azhar Abdulrahman Ali Saleh Al-wesabi, phD student, Cairo University
ClinicalTrials.gov Identifier: NCT03964766    
Other Study ID Numbers: 200277
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: study will be available within 2 year.
Access Criteria: Not yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Azhar Abdulrahman Ali Saleh Al-wesabi, Cairo University:
rotary files
Primary molar
Pulpectomy