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

NCT03161639 — Not applicable, Unknown, 64 participants, Universidade Federal de Santa Catarina

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

RegistryNCT03161639
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment64 (Estimated)
SponsorUniversidade Federal de Santa Catarina (Other)
ConditionsEndodontically Treated Teeth
InterventionsPulpectomies (Other)
Datesstart 2016-09-02, primary completion 2018-12-02, completion 2020-09-02 (estimated), first posted 2017-05-22, last updated 2018-12-26
Locations2 sites in Brazil

Related Papers Related Patents Related Grants Related Experts
All trials for Endodontically Treated Teeth All trials of Pulpectomies

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Operator 1No interventionPerform the pulpectomies except the working length measurement
Operator 2No interventionPerform the electronic length measurement of the pulpectomies
Operator 3Active comparatorOther: PulpectomiesPerform radiographic length measurement and final evaluation of the pulpectomies
  • Pulpectomies (Other): 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.

+Outcome measures

Primary outcomes

  • Outcome Electronic Apex locator [Evaluations will be done during 24 mouths after the pulpectomy performance]: 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 outcomes

  • Difference in length measurement methods for pulpectomies in primary teeth [Evaluations will be done during the pulpectomy performance]: 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 [Evaluations will be done after the pulpectomy performance]: Evaluate the effect of two working length measurement methods in the obturation level of pulpectomy in primary teeth

+Eligibility

Sex: All, ages: 6 Years to 9 Years, accepts 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

+Locations (2)

FacilityCityCountryStatus
Nashalie Andrade de AlencarFlorianópolis, Santa CatarinaBrazil
Universidade Federal de Santa CatarinaFlorianópolis, Santa CatarinaBrazil

+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. PMID 20951282

+Investigators