Mechanized Instrumentation for Endodontic Treatment of Primary Teeth

Not Applicable

Completed

• Conditions: Endodontic Treatment of Primary Teeth
• Interventions: Procedure: Reciprocating Instrumentation; Procedure: Manual instrumentation

• Registration Number: NCT03453658
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-11-08
• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-03-05
• Primary Completion: 2018-08-31
• Study Completion: 2021-01-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Success or failure of endodontic treatment	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

Name	Time	Method
Cost-Efficacy of each instrumentation technique	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.
Quality of obturation provided by two different instrumentation techniques	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.
Discomfort related to each instrumentation technique	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).
Appointment duration	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.

Trial Locations

Locations (1)

School of Dentistry, University of Sao Paulo; 🇧🇷 Sao Paulo, Brazil