NCT03488836

Brief Summary

extrusion of infected dentin into the periapical tissue has been suggested as a major source of pain after endodontic treatment. Although debris extrusion is an inevitable finding even when instrumentation is limited to the confines of the canal, different armamentarium seem to be associated with different amounts of debris extrusion. Studies on the effect of various rotary files on post-endodontic pain are very few and have yielded conflicting results with some favoring full-sequence and others leaning towards reciprocal rotary systems. This study aims at assessing the intensity of post-endodontic pain following two different rotary systems, Reciproc and race. Methods: in this single-blind, parallel-grouped randomized clinical trial a total of 150 otherwise healthy patients aged between 20 to 50 years old with a pulpal status of irreversible pulpitis for one tooth in the upper or lower molar region were analyzed. A clinician performed the endodontic treatment in two groups, a group instrumented using race and a third group with instrumentation performed using Reciproc rotary systems.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 4, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

May 2, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2018

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

February 4, 2018

Last Update Submit

April 4, 2018

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (1)

  • change of the Visual analogue scale

    change of the vas evaluation

    6-12-18-24-48-72 hours

Study Arms (2)

race

ACTIVE COMPARATOR

race rotation protocol

Procedure: reciproc

reciproc

ACTIVE COMPARATOR

reciprocal endodontic treatment group

Procedure: race rotary

Interventions

reciprocPROCEDURE

rotary reciprocating protocol

race
race rotaryPROCEDURE

race rotary group protocol

reciproc

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental clinic of BandarAbbas faculty of dentistry

Bandar Abbas, Hormozgan, Iran

RECRUITING

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

February 4, 2018

First Posted

April 5, 2018

Study Start

May 2, 2018

Primary Completion

July 2, 2018

Study Completion

November 2, 2018

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

IR(1)