Clinical trial NCT03161639: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Endodontically Treated Teeth
Keywords: Pulpectomy
Primary teeth
Working length
Apex locator
Lead sponsor: Universidade Federal de Santa Catarina
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 64
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Outcome Electronic Apex locator
timeFrame: Evaluations will be done during 24 mouths after the pulpectomy performance
Secondary outcomes:
measure: Difference in length measurement methods for pulpectomies in primary teeth
timeFrame: Evaluations will be done during the pulpectomy performance
measure: Influence of working length measurement methods in the obturation level of pulpectomy in primary teeth
timeFrame: Evaluations will be done after the pulpectomy performance
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Nashalie Andrade de Alencar
state: Santa Catarina
city: Florianópolis
country: Brazil
facility: Universidade Federal de Santa Catarina
state: Santa Catarina
Study officials:
affiliation: Universidade Federal de Santa Catarina
name: Nashalie Alencar, Ms
role: PRINCIPAL_INVESTIGATOR
References:
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.