Single-file Pulpectomy in Primary Molars

May 14, 2020 updated by: Osama Seif El-Nasr Hussein Gad El-Hak, Minia University

Efficacy of One-Shape Single-file System in Pulpectomy of Infected Primary Molars: In-vitro and In-vivo Randomized Controlled Trial.

The current study evaluates the rotational One Shape single-file system regarding clinical and radiographic outcomes in root canal treatment of infected primary molars.

This randomized clinical trial was carried out on 94 primary molars on children in the age group from 4 to 6 years. The teeth selected for this study were randomly assigned into 2 groups according to the used endodontic preparation system. Group I: 47 primary molars were instrumented with One Shape rotational single-file system. Group II: 47 primary molars were instrumented with stainless steel K-files. All teeth were evaluated clinically and radigraphically for 12 months with periodic recall at 3, 6 and 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

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, 61517
        • Minia University, Faculty of Dentistry.

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 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children categorized as class I or II according to American Society of Anesthesiologists (ASA).
  • Children aged between 4 and 6 years with at least one necrotic primary second mandibular molar.
  • History of dull toothache over an extended period of time
  • History of spontaneous pain or pain at night
  • Swelling adjacent to tooth with or without a sinus tract
  • Abnormal tooth mobility
  • Presence of necrotic pulp tissue or purulent discharge when the pulp chamber was accessed
  • Interruption of lamina dura or thickening of periodontal ligament space
  • Furcational radiolucency did not surpass half of the distance between the furcation and permanent successor
  • Negative findings of internal root resorption
  • External root resorption confined to the apical third and with at least two-thirds of the root length was intact

Exclusion Criteria:

  • Uncoperative children or parents/legal guardians
  • Sever intellectual, behaviour or emotional problems
  • Non-restorable tooth crowns
  • Root canal obliteration
  • Presence of underlying dentigerous or follicular cysts

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: One Shape Single-file rotary system
Other: One Shape Single-file rotary system
rotational single file system used for mechanical debridement of root canals
ACTIVE_COMPARATOR: Manual stainless steel K-file
Other: manual stainless steel K-file
sequential manual filing with stainless steel K-files

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain presence or absence
Time Frame: one year
score 0 was applied for absence of pain and score 1 was applied for presence of pain
one year
swelling presence or absence
Time Frame: one year
score 0 was applied for absence of swelling and score 1 was applied for presence of swelling
one year
radiographic success or failure
Time Frame: one year
it was done using periapical radiograph and score 0 was applied for absence of radiolucency and score 1 was applied for presence of radiolucency
one year

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)

June 15, 2017

Primary Completion (ACTUAL)

December 22, 2019

Study Completion (ACTUAL)

March 2, 2020

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (ACTUAL)

May 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 42/183/11/2016

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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