MedDataX Logo

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

NCT ID: NCT03161639

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-02

Study Completion Date

2020-09-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endodontically Treated Teeth

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Pulpectomy Primary teeth Working length Apex locator

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Operator 1

Perform the pulpectomies except the working length measurement

Group Type NO_INTERVENTION

No interventions assigned to this group

Operator 2

Perform the electronic length measurement of the pulpectomies

Group Type NO_INTERVENTION

No interventions assigned to this group

Operator 3

Perform radiographic length measurement and final evaluation of the pulpectomies

Group Type ACTIVE_COMPARATOR

Pulpectomies

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal de Santa Catarina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nashalie Andrade de Alencar

Pediatric dentistry PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nashalie Alencar, Ms

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Santa Catarina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nashalie Andrade de Alencar

Florianópolis, Santa Catarina, Brazil

Site Status

Universidade Federal de Santa Catarina

Florianópolis, Santa Catarina, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 20951282 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Universidade Federal SC

Identifier Type: -

Identifier Source: org_study_id