Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth

Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth - Randomized Clinical Trial

Verify, through a randomized double-blinded clinical trial, the influence in the performance of pulpectomies in primary teeth, based on two working length methods, electronic and radiographic.

Study Overview

• Status: Unknown
• Conditions: Endodontically Treated Teeth
• Intervention / Treatment: Other: Pulpectomies

Detailed Description

Samples will be composed of children between 6 and 9 years of age, with the need for endodontic treatment in primary teeth. They will be submitted to anamnesis, clinical and radiographic exams for identification of eligibility criteria for the study. These patients will be divided randomly into 2 groups: G1 - pulpectomy with working length method performed through radiography (n=100) and G2 - pulpectomy with working length method performed with the aid of an apex locator (n=100). Endodontic treatment will be done by a single trained operator. After definite restoration and final radiography, an evaluation of the obturation quality will be performed by another blinded operator, who will evaluate the appropriate obturation length. The clinical treatment success and the radiographies will also be analyzed during a period of 24 months through clinical and radiographic exams, also by a blinded operator.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Florianópolis, Santa Catarina, Brazil, 88030-680
      • Nashalie Andrade de Alencar
    • Florianópolis, Santa Catarina, Brazil, 88030-680
      • Universidade Federal de Santa Catarina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary molars teeth with caries or defected restorations associated with signs or symptoms of irreversible pulpal inflammation - spontaneous pain or pulpal necrosis - presence of abscess, fistula, edema, periapical or inter-radicular radiolucency

Exclusion Criteria:

• Primary molars teeth previously manipulated, with obliteration of the root canal, with bone reabsorption involving the crypt of the permanent tooth, internal or external pathological or physiological reabsorption involving more then half of the shortest root and unrestorable tooth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Operator 1; Perform the pulpectomies except the working length measurement
No Intervention: Operator 2; Perform the electronic length measurement of the pulpectomies
Active Comparator: Operator 3; Perform radiographic length measurement and final evaluation of the pulpectomies	Other: Pulpectomies; Primary teeth pulpectomy is an important treatment option for necrotic teeth. The correct working length will determine a better chemical and mechanical disinfection of the root canals, without demanding the surrounding periapical tissues and dental germs. In addition, it decreases the chance of a sub or over-filling, which also may interfere with the achievement of the success.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Outcome Electronic Apex locator	The use of an electronic apex locator for the achievement of working length in primary teeth pulpectomies will demonstrate a similar or better result than the radiographic method for the obturation adequacy. Also it will show a closer or a better result in the evaluation of the clinical and radiographic success in a long-term treatment.	Evaluations will be done during 24 mouths after the pulpectomy performance

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in length measurement methods for pulpectomies in primary teeth	Evaluate if there is a significant difference in the accuracy of electronic apex locators compared to the conventional radiography in working length measurements	Evaluations will be done during the pulpectomy performance
Influence of working length measurement methods in the obturation level of pulpectomy in primary teeth	Evaluate the effect of two working length measurement methods in the obturation level of pulpectomy in primary teeth	Evaluations will be done after the pulpectomy performance

Collaborators and Investigators

• Sponsor: Universidade Federal de Santa Catarina
• Investigators: Principal Investigator: Nashalie Alencar, Ms, Universidade Federal de Santa Catarina

Publications and helpful links

General Publications

• Ravanshad S, Adl A, Anvar J. Effect of working length measurement by electronic apex locator or radiography on the adequacy of final working length: a randomized clinical trial. J Endod. 2010 Nov;36(11):1753-6. doi: 10.1016/j.joen.2010.08.017. Epub 2010 Sep 19.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2016
• Primary Completion (Actual): December 2, 2018
• Study Completion (Anticipated): September 2, 2020

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 22, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Pulpectomy; Primary teeth; Working length; Apex locator
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: Universidade Federal SC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No