NCT05289973

Brief Summary

The aim of the present study is to clinically compare the incidence of postoperative pain after root canal preparation using TruNatomy system and HyFlex Electrical Discharge Machined (EDM) rotary system in asymptomatic necrotic mandibular molars.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

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 22, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

5 months

First QC Date

December 22, 2021

Last Update Submit

July 18, 2022

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain

    The pain will be recorded according to the modified visual analogue scale. The scale consists of a line marked from 1 to 10 where 10 represent the most intense pain imaginable and the worst outcome.

    Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.

Secondary Outcomes (1)

  • Number of analgesics taken by the patient after endodontic treatment

    up to 7 days post-operatively

Study Arms (2)

TruNatomy Files

EXPERIMENTAL

Newly introduced endodontic file

Device: TruNatomy Files

Hyflex EDM

EXPERIMENTAL

Endodontic file

Device: HyFlex EDM Files

Interventions

TruNatomy FilesDEVICE

Newly introduced endodontic file with high flexibility.

TruNatomy Files
HyFlex EDM FilesDEVICE

Endodontic files

Hyflex EDM

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 25 - 45 years old.
  • Males or Females.
  • Mandibular molar teeth with:
  • No pain.
  • No response to pulp testing.
  • Radiographic appearance with or without a periapical radiolucency.

You may not qualify if:

  • Patients with pre-operative pain.
  • Patients having significant systemic disorders.
  • Patients who are allergic to non-steroidal anti-inflammatory drugs.
  • Patients with two or more adjacent teeth requiring root canal therapy.
  • Teeth that have:
  • Vital pulp tissues.
  • Association with swelling or fistulous tract.
  • Acute or chronic peri-apical abscess.
  • Greater than grade I mobility.
  • Pocket depth greater than 5mm.
  • No possible restorability.
  • Previous endodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Thompson SA. An overview of nickel-titanium alloys used in dentistry. Int Endod J. 2000 Jul;33(4):297-310. doi: 10.1046/j.1365-2591.2000.00339.x.

    PMID: 11307203BACKGROUND

  • Arias A, de la Macorra JC, Hidalgo JJ, Azabal M. Predictive models of pain following root canal treatment: a prospective clinical study. Int Endod J. 2013 Aug;46(8):784-93. doi: 10.1111/iej.12059. Epub 2013 Feb 12.

    PMID: 23402273BACKGROUND

  • Ruiz-Hubard EE, Gutmann JL, Wagner MJ. A quantitative assessment of canal debris forced periapically during root canal instrumentation using two different techniques. J Endod. 1987 Dec;13(12):554-8. doi: 10.1016/S0099-2399(87)80004-3. No abstract available.

    PMID: 3482231BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Angie Ghoneim, PHD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Nora El Khater, B.D.S

CONTACT

02-01063918844nora.khater@dentistry.cu.edu.eg

Angie Ghoneim, PHD

CONTACT

angie.ghoneim@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: patients having mandibular molars with necrotic pulp
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 22, 2021

First Posted

March 22, 2022

Study Start

August 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

July 19, 2022

Record last verified: 2022-07