Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth - Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 64
- Locations
- 2
- Primary Endpoint
- Outcome Electronic Apex locator
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, 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.
Eligibility Criteria
- Ages
- 6 Years to 9 Years (Child)
- Sex
- 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
- •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
Arms & Interventions
Operator 1
Perform the pulpectomies except the working length measurement
Operator 2
Perform the electronic length measurement of the pulpectomies
Operator 3
Perform radiographic length measurement and final evaluation of the pulpectomies
Intervention: Pulpectomies (Other)
Outcomes
Primary Outcomes
Outcome Electronic Apex locator
Time Frame: 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)
- Influence of working length measurement methods in the obturation level of pulpectomy in primary teeth(Evaluations will be done after the pulpectomy performance)
Investigators
Nashalie Andrade de Alencar
Pediatric dentistry PhD student
Universidade Federal de Santa Catarina