Mechanized Instrumentation for Endodontic Treatment of Primary Teeth

NCT03453658 | Completed

• 1 other identifier: FOUSP2912
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontic Treatment of Primary Teeth

Keywords

Endodontics; Primary Teeth; Reciprocating instrumentation; Mechanized instrumentation

Outcome Measures

Primary Outcomes (1)

• Success or failure of endodontic treatment

  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 Outcomes (4)

• Appointment duration

  After treatment

• Quality of obturation provided by two different instrumentation techniques

  After treatment

• Discomfort related to each instrumentation technique

  After treatment.

• Cost-Efficacy of each instrumentation technique

  Two years

Study Arms (2)

Manual instrumentation

ACTIVE COMPARATOR

Manual instrumentation: Endodontic treatment will be performed with the use of conventional endodontic manual files.

Procedure: Manual instrumentation

Reciprocating instrumentation

EXPERIMENTAL

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

Interventions

Manual instrumentation PROCEDURE

Manual conventional files will be used in endodontic treatment of primary teeth

Manual instrumentation

Reciprocating Instrumentation PROCEDURE

Reciprocating files system will be used in endodontic treatment of primary teeth.

Reciprocating instrumentation

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry, University of Sao Paulo

São Paulo, 05508-000, Brazil

Location

Related Publications (19)

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Study Officials

• Renata Marques, PhD Student

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be a different examiner who will be unaware of the allocated group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized, single-blind, controlled clinical trial with two parallel arms.

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 5, 2018
• Study Start: November 8, 2017
• Primary Completion: August 31, 2018
• Study Completion: January 28, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

BR (1)