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

Endodontically Treated Teeth Clinical Trial

Official title:

Influence of Working Length Methods in the Performance of Pulpectomies in Primary Teeth - Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03161639
• Other study ID #: Universidade Federal SC
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2, 2016
• Est. completion date: September 2, 2020

Study information

• Verified date: December 2018
• Source: Universidade Federal de Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: September 2, 2020
• Est. primary completion date: December 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Endodontically Treated Teeth
• Tooth, Nonvital

Intervention

Other:
• Pulpectomies
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.

Locations

Country	Name	City	State
Brazil	Nashalie Andrade de Alencar	Florianópolis	Santa Catarina
Brazil	Universidade Federal de Santa Catarina	Florianópolis	Santa Catarina

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Catarina

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in length measurement methods for pulpectomies in primary teeth	Evaluate if there is a significant difference in the accuracy of electronic apex locators compared to the conventional radiography in working length measurements	Evaluations will be done during the pulpectomy performance
Secondary	Influence of working length measurement methods in the obturation level of pulpectomy in primary teeth	Evaluate the effect of two working length measurement methods in the obturation level of pulpectomy in primary teeth	Evaluations will be done after the pulpectomy performance