Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain

Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain in Asymptomatic Necrotic Molars.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05289973

Acronym

TRN

Enrollment

Registered

2022-03-22

Start date

2022-08-01

Completion date

2023-02-01

Last updated

2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endodontically Treated Teeth

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.

Detailed description

Up till now, there are no clinical studies on the effect of instrumentation using TruNatomy files on post-operative pain. Furthermore, these newly introduced files can provide more affordable means for instrumentation. Therefore, the purpose of this study is to clinically compare the effect of using TruNatomy files and HyFlex EDM files on post-operative pain.

Interventions

DEVICETruNatomy Files

Newly introduced endodontic file with high flexibility.

DEVICEHyFlex EDM Files

Endodontic files

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

patients having mandibular molars with necrotic pulp

Eligibility

Sex/Gender

ALL

Age

25 Years to 45 Years

Healthy volunteers

Inclusion criteria

1. Age between 25 - 45 years old. 2. Males or Females. 3. Mandibular molar teeth with: * No pain. * No response to pulp testing. * Radiographic appearance with or without a periapical radiolucency.

Exclusion criteria

1. Patients with pre-operative pain. 2. Patients having significant systemic disorders. 3. Patients who are allergic to non-steroidal anti-inflammatory drugs. 4. Patients with two or more adjacent teeth requiring root canal therapy. 5. 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.

Design outcomes

Primary

Measure	Time frame	Description
Post-operative pain : measure pain level change from zero(no pain) pain Post-operative pain Post-operative pain	Post-operative pain measured 6, 12, 24, 48, 72 hours and 7 days post-operatively.	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.

Secondary

Measure	Time frame	Description
Number of analgesics taken by the patient after endodontic treatment	up to 7 days post-operatively	Counting Number of analgesics taken by the patient after endodontic treatment

Contacts

Primary ContactNora El Khater, B.D.S

nora.khater@dentistry.cu.edu.eg02-01063918844

Backup ContactAngie Ghoneim, PHD

angie.ghoneim@dentistry.cu.edu.eg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026