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Mechanized Instrumentation for Endodontic Treatment of Primary Teeth

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. Read our disclaimer for details. Identifier: NCT03453658
Recruitment Status : Suspended (Follow-ups paused temporarily since March 16th, 2020 due to COVID-19.)
First Posted : March 5, 2018
Last Update Posted : May 26, 2020
Information provided by (Responsible Party):
Fausto Medeiros Mendes, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endodontic Treatment of Primary Teeth Procedure: Manual instrumentation Procedure: Reciprocating Instrumentation Not Applicable

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%.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, single-blind, controlled clinical trial with two parallel arms.
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor will be a different examiner who will be unaware of the allocated group.
Primary Purpose: Treatment
Official Title: Evaluation of Mechanized Instrumentation for Endodontic Treatment of Primary Teeth - Randomized Clinical Trial
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : August 31, 2018
Estimated Study Completion Date : February 28, 2021

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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT03453658

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School of Dentistry, University of Sao Paulo
Sao Paulo, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
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Principal Investigator: Renata Marques, PhD Student University of Sao Paulo

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Responsible Party: Fausto Medeiros Mendes, Associate professor, University of Sao Paulo Identifier: NCT03453658    
Other Study ID Numbers: FOUSP2912
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are planning to share the individual data upon request, since the participants and their legal guardians consent.

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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 Fausto Medeiros Mendes, University of Sao Paulo:
Primary Teeth
Reciprocating instrumentation
Mechanized instrumentation