NCT04216940

Brief Summary

Assess the pain intensity in a two visit treatment of molars with irreversible pulpitis after instrumentation with two rotary systems Mpro and Hyflex files.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 10, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
Last Updated

January 3, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

December 24, 2019

Last Update Submit

January 2, 2020

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Pain felt after mechanical instrumentation in the first visit

    using Numeric Rating Scale (NRS) the participant will be asked to verbally rate their pain on a scale from 0 to 10, with 0 equal to no pain and 10 equal to worst possible pain

    up to 72 hours

Study Arms (2)

M-pro

EXPERIMENTAL
Device: mechanical preparation of root canal system

Hyflex

EXPERIMENTAL
Device: mechanical preparation of root canal system

Interventions

mechanical preparation of root canal systemDEVICE

Assess the pain intensity in a two-visit treatment of molars with irreversible pulpitis after instrumentation with two different rotary Nickle Titanium systems

HyflexM-pro

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • mandibular molars with acute pulpitis

You may not qualify if:

  • badly decayed non-restorable molars
  • medically compromised patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

December 24, 2019

First Posted

January 3, 2020

Study Start

February 10, 2019

Primary Completion

August 28, 2019

Study Completion

August 28, 2019

Last Updated

January 3, 2020

Record last verified: 2020-01

Locations

EG(1)