NCT04655105

Brief Summary

The present clinical evaluation was planned for comparing the post-operative pain incidence in maxillary premolar teeth with acute irreversible pulpitis treated by recently introduced heat treated TruNatomy TM and other widely studied heat-treated files Hyflex EDM, Protaper Gold and one heat-treated reciprocating EdgeFile in single-visit root canal treatment.

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
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

January 3, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

December 3, 2020

Last Update Submit

March 29, 2021

Conditions

Root Canal Infection

Outcome Measures

Primary Outcomes (3)

  • post operative pain evaluation using different rotary instruments: VAS score

    pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced \[1-3\] mild pain , \[4-7\] moderate pain , \[8-10\] severe pain

    at 24 hrs

  • post operative pain evaluation using different rotary instruments: VAS score

    pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced \[1-3\] mild pain , \[4-7\] moderate pain , \[8-10\] severe pain

    at 48hrs

  • post operative pain evaluation using different rotary instruments: VAS score

    pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced \[1-3\] mild pain , \[4-7\] moderate pain , \[8-10\] severe pain

    at 7 days

Secondary Outcomes (2)

  • assessment of pain scale using different rotary instruments

    through study completion, an average of 1 week

  • comparing the pain scale experienced between male and female in VAS score

    through study completion, an average of 1 week

Study Arms (4)

Truanatomy rotary file

EXPERIMENTAL

use of tru anatomy rotary files root canal instrumentation followed by post operative pain evaluation

Device: root canal rotary files

hyflex EDM rotary file

EXPERIMENTAL

use of hyflex EDM rotary files root canal instrumentation followed by post operative pain evaluation

Device: root canal rotary files

edge endo reciprocating rotary file

EXPERIMENTAL

use of edge endo reciprocating rotary files root canal instrumentation followed by post operative pain evaluation

Device: root canal rotary files

protaper gold rotary file

ACTIVE COMPARATOR

use of protaper gold rotary files root canal instrumentation followed by post operative pain evaluation

Device: root canal rotary files

Interventions

root canal rotary filesDEVICE

post operative pain evaluation using different rotary file system

Truanatomy rotary fileedge endo reciprocating rotary filehyflex EDM rotary fileprotaper gold rotary file

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSI college of dental sciences and research

Madurai, Tamil Nadu, 625001, India

RECRUITING

Central Study Contacts

Valliappan CT, post graduate (MDS)

CONTACT

08870558925vrvalliappan2@gmail.com

Anand Sherwood, MDS, Ph.D

CONTACT

9791443950anand.sherwood@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post graduate student

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 7, 2020

Study Start

January 3, 2021

Primary Completion

May 3, 2021

Study Completion

June 3, 2021

Last Updated

March 30, 2021

Record last verified: 2021-03

Locations

IN(1)