Post Operative Pain Assessment After Pulpectomy of Primary Molars With Two Different Rotary Systems

September 15, 2021 updated by: Mahmoud Ahmed Mahmoud, Minia University

Post Operative Pain After Pulpectomy of Primary Molars With One Shap Rotation File Versus Wave One Reciprocating File

Evaluation of post operative pain after pulpectomy procedures for primary molars with irreversible pulp damage and without periapical radulicency using two different systems (One shape file ( ratation movemont) and wave one gold file ( reciprocation movement)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61111
        • Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of more than 4 years
  • Healthy children
  • Primary molars with irreversible pulp damage

Exclusion Criteria:

  • Presence of periapical radiolucency realtes to primary molar
  • Uncooperative child

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wave One Gold
Receporcating single file used for preparation of root canals in primary molars
Other: Pulpectomy using single file system ( WaveOne Gold file)
Rotary file instrument for pulpectomy of primary molars ( WaveOne Gold file)
Experimental: One shape
Rotation single file used for preparation of root canals in primary molars
Other: Pulpectomy using single file system ( One Shape file)
Rotary file instrument for pulpectomy of primary molars ( One shape file)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: 1 week

Assessment of pain using 4 piont intensity scale

1 means no pain, 2 means slight pain, 3 means moderate pain and for means sever pain at 6,12, 48,72 hours and 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2021

Primary Completion (Actual)

May 10, 2021

Study Completion (Actual)

June 10, 2021

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 15, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 605

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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