NCT02566486

Brief Summary

Aim The aim of this clinical study was to evaluate the influence of the instrumentation techniques on the incidence and intensity of postoperative pain in single-visit root canal treatment. Methodology Ninety patients with single root/canal and non-vital pulps were included. The patients were assigned into 3 groups according to root canal instrumentation technique used; the modified step-back (stainless-steel hand files, HF), reciprocal (WaveOne, WO), and rotational (ProTaper Next, PTN). Root canal treatment was carried out in a single visit and the severity of postoperative pain was assessed by 4-point pain intensity scale. All the participants were called through phone at 12, 24 and 48 h to obtain the pain scores. Data were analyzed by the Kruskal-Wallis test.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

Enrollment Period

1 month

First QC Date

September 30, 2015

Last Update Submit

October 1, 2015

Conditions

Pulpitis

Outcome Measures

Primary Outcomes (1)

  • 4-point pain intensity scale

    Change from intensity of postoperative pain at 48 hours

    48 hours

Study Arms (2)

Reciprocating system

OTHER

Waveone root canal instrumentation file

Device: Reciprocating system

Rotational system

OTHER

ProTaper Next root canal instrumentation file

Device: Rotational system

Interventions

Reciprocating systemDEVICE

Different root canal instrumentation systems

Also known as: WaveOne
Reciprocating system
Rotational systemDEVICE

Different root canal instrumentation systems

Also known as: ProTaper Next
Rotational system

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • asymptomatic and non-vital teeth associated with periapical lesions

You may not qualify if:

  • vital tooth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 2, 2015

Study Start

November 1, 2013

Primary Completion

December 1, 2013

Study Completion

October 1, 2014

Last Updated

October 2, 2015

Record last verified: 2015-10