Mechanized Instrumentation for Endodontic Treatment of Primary Teeth

March 23, 2021 updated by: Fausto Medeiros Mendes, University of Sao Paulo

Evaluation of Mechanized Instrumentation for Endodontic Treatment of Primary Teeth - Randomized Clinical Trial

Mechanized instrumentation systems stand out amongst various devices used in modern Endodontics. Its use in Pediatric Dentistry, its action in primary teeth, has been in the center of many discussions and laboratory studies. Nevertheless, up to now, a lack of clinical studies on this issue can be found. Our objective is to conduct a double blinded, 2 years follow up clinical trial to compare the success of endodontic treatment in primary teeth using mechanized reciprocating instrumentation to the use of manual instrumentation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With the approval of the Ethics Committee of University of São Paulo, after clinical and radiographic examination, patients in search for endodontic treatment in primary teeth will be invited to take part in the study. The participants of the study will be randomized to one of two groups (manual or reciprocating instrumentation). Endodontic treatment will be held by a specialist according to the randomized group. A blinded examiner will proceed one week, 3 months, 6 months, 12 months and 24 months follow ups. Clinical and radiographic conditions of endodontic treatments will be analyzed to classify them as Success or Failure. The unit of analysis will be the teeth; hence, each participant may have more than one tooth included in the study. The randomization will be performed considering the tooth. Data analysis will consider the cluster nature of the sample.

The primary outcome of the study will be the success rates according to the groups. The longevity of treatments will be evaluated by estimating survival rates by Kaplan-Meier and Cox regression. The differences between survival rates of both groups will be through Cox regression adjusted for the cluster nature of the sample (more than one tooth per participant), considering a level of significance of 5%.

Study Type

Interventional

Enrollment (Actual)

151

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

  • Brazil
      • Sao Paulo, Brazil, 05508-000
        • School of Dentistry, University of Sao Paulo

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

3 years to 9 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary molar teeth with necessity of endodontic treatment.
  • Patients whose parents or guardians consent to their participation in the study

Exclusion Criteria:

Teeth presenting one of the following:

  • Resorption of more than 2/3 of the root
  • Destruction of the crypt of the permanent successor
  • Pulp chamber floor drilling.
  • Presence of internal resorption

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
ACTIVE_COMPARATOR: Manual instrumentation
Manual instrumentation: Endodontic treatment will be performed with the use of conventional endodontic manual files.
Procedure: Manual instrumentation
Manual conventional files will be used in endodontic treatment of primary teeth
EXPERIMENTAL: Reciprocating instrumentation
Mechanized instrumentation: Endodontic treatment will be performed with the use of reciprocating mechanized files. The files are activated by an engine that produces reciprocating movements.
Procedure: Reciprocating Instrumentation
Reciprocating files system will be used in endodontic treatment of primary teeth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success or failure of endodontic treatment
Time Frame: Two years
The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: absence / reduction of periapical bone rarefaction in anterior and absence / bone rarefaction in the furcation area of later, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions will be between the initial and follow-up radiographs. Radiographs will be scanned and the end of the bone rarefactions starting area and will be measured on a software image analysis.
Two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appointment duration
Time Frame: After treatment
The time spent using both techniques will be measured and compared between the groups. The time will be recorded in minutes since the end of anesthesia and rubber-dam placement until the beginning of restorative procedure.
After treatment
Quality of obturation provided by two different instrumentation techniques
Time Frame: After treatment
After root canal obturation, a final periapical radiograph will be digitalized and analyzed, obtaining the percentage of root canal filling provided by each instrumentation technique.
After treatment
Discomfort related to each instrumentation technique
Time Frame: After treatment.
Discomfort provided by each technique will be analyzed and compared between the groups using a validated facial scale, named Wong-Baker facial scale. This is a scale of 6 drawn faces ranging from a smiling representing no hurt face to as crying hurts worst face. Therefore, the scale has been used to evaluate pain and/or discomfort after several procedures, including dental procedures. The answers can be measured as a qualitative ordinal variable varying from 0 (no hurt) to 5 (Hurts worst). This scale has been used previously in pediatric dentistry context (Tomlinson et al., 2010).
After treatment.
Cost-Efficacy of each instrumentation technique
Time Frame: Two years
The cost-efficacy of each procedure will be analyzed according to the success rate of each technique, and the results obtained will be compared.
Two years

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Renata Marques, PhD Student, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 8, 2017

Primary Completion (ACTUAL)

August 31, 2018

Study Completion (ACTUAL)

January 28, 2021

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

February 27, 2018

First Posted (ACTUAL)

March 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FOUSP2912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We are planning to share the individual data upon request, since the participants and their legal guardians consent.

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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