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

Not Applicable

• Conditions: Endodontically Treated Teeth
• Interventions: Other: Pulpectomies

• Registration Number: NCT03161639
• Lead Sponsor: Universidade Federal de Santa Catarina

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.

Study Timeline

• Study Start: 2016-09-02
• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-22
• Status Verified: 2018-12
• Primary Completion: 2018-12-02
• Last Update Submitted: 2018-12-22
• Last Update Posted: 2018-12-26
• Study Completion: 2020-09-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Operator 3	Pulpectomies	Perform radiographic length measurement and final evaluation of the pulpectomies

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Universidade Federal de Santa Catarina; 🇧🇷 Florianópolis, Santa Catarina, Brazil

Nashalie Andrade de Alencar; 🇧🇷 Florianópolis, Santa Catarina, Brazil