Mechanized Instrumentation for Endodontic Treatment of Primary Teeth

University of Sao Paulo

Status: Completed

Conditions: Endodontic Treatment of Primary Teeth

Treatments: Procedure: Manual instrumentation; Procedure: Reciprocating Instrumentation

Study type: Interventional

Funder types: Other

Identifiers

NCT03453658

FOUSP2912

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 151 patients

Sex: All

Ages: 3 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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151 participants in 2 patient groups

Manual instrumentation

Active Comparator group

Description:

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

Treatment:

Procedure: Manual instrumentation

Reciprocating instrumentation

Experimental group

Description:

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.

Treatment:

Procedure: Reciprocating Instrumentation