NCT02442388

Brief Summary

The purpose of this prospective, randomized, double-blind study was to compare the prospective pain in asymptomatic mandibular molar teeth with necrotic pulp and periapical lesion using three different instrumentation files: Hand, Protaper Universal, and Wave-One files.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
Last Updated

May 13, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

May 7, 2015

Last Update Submit

May 8, 2015

Conditions

Keywords

painroot canal therapyendodonticsfile

Outcome Measures

Primary Outcomes (1)

  • Pain as assessed by Heft-Parker VAS

    Pain as assessed by Heft-Parker VAS

    After each technique, up to 72 hours

Study Arms (3)

Hand file

EXPERIMENTAL

Instrumentation technique

Procedure: Instrumentation technique with hand file

ProTaper file

EXPERIMENTAL

Instrumentation technique

Procedure: Instrumentation technique with ProTaper

Wave-One file

EXPERIMENTAL

Instrumentation technique

Procedure: Instrumentation technique with WaveOne

Interventions

type of instrumentation technique for root canal treatment

Hand file

type of instrumentation technique for root canal treatment

ProTaper file

type of instrumentation technique for root canal treatment

Wave-One file

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy patient

You may not qualify if:

  • Allergy to anesthetics, pregnancy, breastfeeding, vital teeth, unrestorable teeth, and teeth associated with pain or swelling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
AssistantProfessor

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 13, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 13, 2015

Record last verified: 2015-05