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

NCT03161639 | Unknown DMC

• 1 other identifier: Universidade Federal SC
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Endodontically Treated Teeth

Keywords

Pulpectomy; Primary teeth; Working length; Apex locator

Outcome Measures

Primary Outcomes (1)

• Outcome Electronic Apex locator

  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.

  Evaluations will be done during 24 mouths after the pulpectomy performance

Secondary Outcomes (2)

• 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

Study Arms (3)

Operator 1

NO INTERVENTION

Perform the pulpectomies except the working length measurement

Operator 2

NO INTERVENTION

Perform the electronic length measurement of the pulpectomies

Operator 3

ACTIVE COMPARATOR

Perform radiographic length measurement and final evaluation of the pulpectomies

Other: Pulpectomies

Interventions

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.

Operator 3

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Santa Catarina: lead

Study Sites (2)

Nashalie Andrade de Alencar

Florianópolis, Santa Catarina, 88030-680, Brazil

Location

Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, 88030-680, Brazil

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Pulpectomy

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Nashalie Alencar, Ms

  Universidade Federal de Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric dentistry PhD student

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 22, 2017
• Study Start: September 2, 2016
• Primary Completion: December 2, 2018
• Study Completion: September 2, 2020
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

BR (2)