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Status unknownNCT03161639Updated Dec 26, 2018

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

An interventional study of Pulpectomies in Endodontically Treated Teeth, sponsored by Universidade Federal de Santa Catarina. Status unknown at 2 sites in Brazil. Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-26.

Sponsored by Universidade Federal de Santa Catarina · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Sep 2016, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Endodontically Treated Teeth

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Keywords

  • Pulpectomy
  • Primary teeth
  • Working length
  • Apex locator
03

In context

Tooth, Nonvital

113 studies on the registry are indexed under Tooth, Nonvital; 19 are open to participants now.

This study's planned enrollment of 64 is above the median of 50 across 103 interventional studies indexed under Tooth, Nonvital.

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Lead sponsor

Universidade Federal de Santa Catarina is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
64 participants (estimated)

Study arms

  • 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

Interventions

  • OtherPulpectomies

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Evaluations will be done during 24 mouths after the pulpectomy performance

Secondary outcomes

  1. 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

    Time frame: Evaluations will be done during the pulpectomy performance

  2. 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

    Time frame: Evaluations will be done after the pulpectomy performance

07

Study locations

2 sites
  • Nashalie Andrade de Alencar
    Florianópolis, Santa Catarina 88030-680, Brazil
  • Universidade Federal de Santa Catarina
    Florianópolis, Santa Catarina 88030-680, Brazil
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References and documents

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. PubMed 20951282 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03161639
Lead sponsor
Universidade Federal de Santa Catarina
Responsible party
Nashalie Andrade de Alencar (Pediatric dentistry PhD student, Universidade Federal de Santa Catarina) — Principal investigator
First posted
May 22, 2017
Start date
Sep 2, 2016
Primary completion
Dec 2, 2018
Completion
Sep 2, 2020 (estimated)
Last update
Dec 26, 2018

Study contacts

Nashalie Alencar, Ms
principal investigator · Universidade Federal de Santa Catarina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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