NCT02905773

Brief Summary

The aim of this study was to evaluate the intensity and duration of postoperative pain after the removal of root canal filling material in retreatment procedures of upper incisor teeth with chronic apical periodontitis, using different techniques. The patients were assigned to three groups of 45 patients, according to the method used to remove old canal filling material. The presence of postoperative pain was assessed after 6, 12, 24, 48, and 72 hours, 7 days, and finally after 10 days. The hypothesis of this study: there would be no difference in postoperative pain intensity among the groups.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for early_phase_1 postoperative-pain

Timeline
Completed

Started Mar 2015

Typical duration for early_phase_1 postoperative-pain

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

March 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

1.2 years

First QC Date

September 6, 2016

Last Update Submit

September 18, 2016

Conditions

Postoperative Pain

Keywords

Intensity

Outcome Measures

Primary Outcomes (1)

  • postoperative pain after non-surgical endodontic retreatment using modified visual analog scale

    10 days

Study Arms (2)

postoperative pain

OTHER

postoperative pain

Other: root canal therapy

intensity

OTHER

intensity

Other: root canal retreatment

Interventions

root canal therapyOTHER

effect of devices ( ProTaper and Reciprocal Files)

postoperative pain
root canal retreatmentOTHER

effect of devices ( ProTaper and Reciprocal Files)

intensity

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • asymptomatic incisor teeth with chronic apical periodontitis
  • patients between 18-55 years of age

You may not qualify if:

  • patients with systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Root Canal Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

EndodonticsDentistry

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 19, 2016

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 20, 2016

Record last verified: 2016-09