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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03161639
Enrollment
64
Registered
2017-05-22
Start date
2016-09-02
Completion date
2020-09-02
Last updated
2018-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endodontically Treated Teeth

Keywords

Pulpectomy, Primary teeth, Working length, Apex locator

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.

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.

Sponsors

Universidade Federal de Santa Catarina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes 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.

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.

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Outcome Electronic Apex locatorEvaluations will be done during 24 mouths after the pulpectomy performanceThe 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

MeasureTime frameDescription
Difference in length measurement methods for pulpectomies in primary teethEvaluations will be done during the pulpectomy performanceEvaluate 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 teethEvaluations will be done after the pulpectomy performanceEvaluate the effect of two working length measurement methods in the obturation level of pulpectomy in primary teeth

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026