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

Primary Purpose

Endodontically Treated Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pulpectomies
Sponsored by
Universidade Federal de Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontically Treated Teeth focused on measuring Pulpectomy, Primary teeth, Working length, Apex locator

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nashalie Andrade de Alencar
  • Universidade Federal de Santa Catarina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

No Intervention

Active Comparator

Arm Label

Operator 1

Operator 2

Operator 3

Arm Description

Perform the pulpectomies except the working length measurement

Perform the electronic length measurement of the pulpectomies

Perform radiographic length measurement and final evaluation of the pulpectomies

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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

Full Information

First Posted
May 18, 2017
Last Updated
December 22, 2018
Sponsor
Universidade Federal de Santa Catarina
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1. Study Identification

Unique Protocol Identification Number
NCT03161639
Brief Title
Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth
Official Title
Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth - Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2, 2016 (Actual)
Primary Completion Date
December 2, 2018 (Actual)
Study Completion Date
September 2, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Catarina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontically Treated Teeth
Keywords
Pulpectomy, Primary teeth, Working length, Apex locator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients between 6 and 9 years old who search for endodontic treatment in primary teeth. The allocation of subjects to groups will be achieved by randomization. These patients will be randomly divided into 2 groups: G1 - pulpectomy with length measurement performed through radiography and G2 - pulpectomy with length measurement performed with the aid of an apex locator.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
At the end of the canal access, the first operator will leave the surroundings and a second operator will continue. A length measurement will be determined in order to define the working length. After the working measurement length performed by the second operator, the first operator will be informed about the working length of each canal without the knowledge of which method was used for the length measurement . From then on, the first operator will continue the endodontic treatment. A third operator will evaluate the outcomes.
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Operator 1
Arm Type
No Intervention
Arm Description
Perform the pulpectomies except the working length measurement
Arm Title
Operator 2
Arm Type
No Intervention
Arm Description
Perform the electronic length measurement of the pulpectomies
Arm Title
Operator 3
Arm Type
Active Comparator
Arm Description
Perform radiographic length measurement and final evaluation of the pulpectomies
Intervention Type
Other
Intervention Name(s)
Pulpectomies
Intervention Description
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.
Primary Outcome Measure Information:
Title
Outcome Electronic Apex locator
Description
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.
Time Frame
Evaluations will be done during 24 mouths after the pulpectomy performance
Secondary Outcome Measure Information:
Title
Difference in length measurement methods for pulpectomies in primary teeth
Description
Evaluate if there is a significant difference in the accuracy of electronic apex locators compared to the conventional radiography in working length measurements
Time Frame
Evaluations will be done during the pulpectomy performance
Title
Influence of working length measurement methods in the obturation level of pulpectomy in primary teeth
Description
Evaluate the effect of two working length measurement methods in the obturation level of pulpectomy in primary teeth
Time Frame
Evaluations will be done after the pulpectomy performance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nashalie Alencar, Ms
Organizational Affiliation
Universidade Federal de Santa Catarina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nashalie Andrade de Alencar
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88030-680
Country
Brazil
Facility Name
Universidade Federal de Santa Catarina
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88030-680
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20951282
Citation
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.
Results Reference
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Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth

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