Effect of TruNatomy and HyFlex EDM Instrumentation on Postoperative Pain (TRN)

Cairo University (CU)

Status: Not yet enrolling

Conditions: Endodontically Treated Teeth

Treatments: Device: TruNatomy Files; Device: HyFlex EDM Files

Study type: Interventional

Funder types: Other

Identifiers

NCT05289973

TRN in postoperative pain

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 25 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

TruNatomy Files

Experimental group

Description:

Newly introduced endodontic file

Treatment:

Device: TruNatomy Files

Hyflex EDM

Experimental group

Description:

Endodontic file

Treatment:

Device: HyFlex EDM Files